Injured by recalled DePuy ASR and Pinnacle Hips? Metallosis, pain and suffering, hip replacement? Read More Here >>
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Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

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Wesley Davis, from New York filed a stroke product liability lawsuit against Actavis and Watson. Davis alleged that the side effects of the testosterone patch AndroDerm caused him to suffer a serious stroke. Furthermore, Davis claimed that the drug manufacturers failed to warn men about the potential risks associated with use of testosterone replacement therapy (TRT).

What is Androderm?

AndroDerm patch is a low testosterone drug approved by the FDA in 1995 for treatment of low testosterone caused by a medical condition, called hypogonadism. The testosterone replacement therapy medication is delivered in permeable skin patches.

Sales for AndroDerm exceeded $87 million in 2011, making it one of the best selling testosterone drugs in America. Testosterone replacement therapy medication sales now exceed $2 billion per year.

Plaintiff’s Allegations

Davis states that AndroDerm was doctor prescribed for low testosterone symptoms. In 2011, Davis was hit hard with a significant stroke, which has left him with serious injuries and medical expenses.

Davis points to the aggressive direct-to-consumer advertising by Actavis and Watson, which cajoled men to seek testosterone medical treatment for normal symptoms associated with aging.

Testosterone Stroke, Heart and Blood Clot Risks

Many injured men have filed AndroDerm, AndroGel, Testim and Axiron lawsuits.  The men allege that the drug manufacturers failed to adequately warn about the risk of heart attacks, strokes, blood clots (deep vein thrombosis and pulmonary embolism) and death associated with the use of testosterone therapy.

Nationwide Testosterone Lawsuit Claims Increasing

The majority of the lawsuits involve personal injuries associated with AndroGel usage. Androgel is a testosterone gel spray manufactured and sold by AbbVie.

Last month, plaintiffs filed a centralization of all AndroGel lawsuits before one U.S. District Judge, as part of an MDL or Multidistrict Litigation. This month, a second motion was filed, requesting all testosterone drug lawsuits to be centralized as part of one consolidated proceeding during pretrial litigation. MDL consolidation and centralization is common in mass tort pharmaceutical litigation, to reduce discovery, and avoid conflicting rulings from different judges.

The U.S. Judicial Panel on Multidistrict Litigation (JPML), which oversees MDL consolidations, has set a hearing over the AndroGel consolidation motion for May 29.

Low Testosterone Medical Studies

In January 2014, according to a study published in the medical journal PLOSOne, low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65.

According to a November 2013 study published in the Journal of the American Medical Association, side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

FDA Launches Investigation

The FDA launched a safety review of AndroGel and other testosterone replacement therapy on January 31.

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U.S. District Judge Herndon, who is presiding over all federal Pradaxa lawsuits has established the pretrial schedule for the first bellwether trial. On September 8, 2014, the first trial will involve the wrongful death lawsuit brought by Suzanne Mackiewicz, on behalf of her mother,  Malachy Higgins.
Pradaxa Wrongful Death AttorneyThe Higgins case is selected as the first out of several thousand lawsuits on file, involving bleeding problems from Pradaxa.Multidistrict Pradaxa Consolidation

All federal product liability lawsuits filed against Boehringer Ingelheim, the manufacturer of Pradaxa have been consolidated as part of an MDL, or Multidistrict Litigation. The MDL is centralized for pre-trial discovery before U.S. District Judge Herndon in the Southern District of Illinois.

Nationwide Pradaxa Claims Over 2,000

There are more than 2,000 Pradaxa personal injury cases before Judge Herndon. The plaintiffs, allege that Boehringer Ingelheim failed to adequately warn consumers and the doctors about the bleeding risk with Pradaxa, or the lack of an effective reversal agent to allow doctors to stop hemorrhages that develop among users.

The court has established a bellwether trial litigation program, where a small group of cases were prepared for early Pradaxa trial dates to help the parties determine similar evidence and testimony. The Higgins lawsuit is the first of four test trials, with additional cases expected to begin in December 2014, February 2015 and March 2015.

Jury selections in the Higgins case are set to begin on September 8, with opening statements expected to begin on September 15. Because the Pradaxa litigation is extremely complex, trial is expected to last several weeks.

If the Higgins plaintiffs are successful, then a potential global Pradaxa settlement may be announced.

What is the problem with Pradaxa?

Pradadxa (dabigatran) is a new anticoagulant therapy that was approved by the FDA in October 2010. Pradaxa is promoted as a superior alternative to warfarin, also known by the brand name Coumadin, for stroke prevention in non valular atrial fibrillation. Atrial fibrillation is a very common heart rthythm abnormality that causes strokes. Unfortunately, Pradaxa is exposed to a record number of adverse event reports after patients experienced uncontrolled bleeding events.

Pradaxa was promoted as a no muss no fuss anticoagulant, because it requires less monitoring. Experts have expressed concerns and grave doubts about the lack of an effective reversal agent to stop the blood thinning effects of Pradaxa.

Warfarin, bleeding side effects can be quickly reversed with a dose of vitamin K and plasma, but there is no available reversal agent for Pradaxa.

There have been thousands of reports of bleeding side effect injuries and hundreds of deaths associated with Pradaxa use since introduction. The Institute for Safe Medication Practices (ISMP) found that adverse event reports involving Pradaxa problems surpassed all other medications regularly monitored by the group. FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa during 2011, including 2,367 reports of hemorrhage and 542 patient deaths.

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According to the FDA, doctors should stop using a procedure performed on thousands of American women a year in the course of hysterectomy uterine surgery, because it increases the risk of spreading cancerous tissue.

toxicThe procedure, power morcellation, cuts uterine tissue into pieces that can be pulled out through the incisions made during laparoscopic surgery. The morcellator devices, have been widely used in laparoscopic operations to remove fibroid tumors from the uterus, or to remove the entire uterus.

Morcellator Devices: No Clinical Trials

Morcellators were allowed onto the market in the 1990s without the usual clinical trials in patients because they were similar to other devices that had already been approved. This is the controversial 510(k) fast track process that medical device experts say lead to current safety debacle with the metal on metal hip implants and other medical devices.

FDA Concerns

The F.D.A. became concerned about morcellators because of recent news reports about patients harmed by them. A cancer case in Boston, first reported in December, focused national attention on the sarcoma cancer risk.  Dr. Reed, a patient, had a hysterectomy because of fibroids in October 2013. A biopsy after the surgery found a hidden sarcoma, an extremely aggressive type of cancer. Morcellation had spread the tumor around inside her pelvis and abdomen, causing advanced Stage 4 cancer.

Hysterectomies is Big Business

According to the FDA, about a half-million women a year have hysterectomies to remove the uterus, and some 50,000 of those operations involve power morcellation of tissue containing fibroid tumors.

Fibroids are benign, but can sometimes hide cancers. If an unsuspected cancer is present, as in Dr. Reed’s case, the rapidly spinning blades of a morcellator can spray cancer cells around and speed the progression of the cancer.

Sarcoma Cancer Spread by Morcellators

Sarcomas are extremely aggressive and almost never detectable before surgery. The diagnosis is usually made only after surgery, when the tissue is biopsied. By then, if a morcellator was used, it is too late to prevent the spread of the cancer, and the woman’s chances of long-term survival are reduced.

Sarcoma Cancer Risks

According to the FDA, one in 350 women who have a hysterectomy or fibroid removal have unsuspected sarcomas. That figure, is considerably higher than estimates that gynecologists had been using, which ranged from one in 500 to one in 10,000.

FDA had the authority to ban morcellators, but did not. The FDA said that doctors and patients could weigh the risks on a case-by-case basis. The FDA emphasized that women must be informed of the risks, something that has not been routinely done, in part because the threat was thought to be low. Many women having hysterectomies were not even told that morcellation was being performed.

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Recently a consolidation motion was filed for all federal Androgel lawsuits to become part of an MDL, or multidistrict litigation.

Hot on the heels of that motion, a second motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting that all testostereone therapy lawsuits be centralized before one judge as a single coordinated proceeding.

If granted, this MDL would be similar to the Byetta, Victoza, Januvia MDL, where the type 2 diabetic drugs have been alleged to have caused pancreatic cancer. The Incretin Mimetic MDL is consolidated in Southern District of Californian, in San Diego.

Benefits of MDL Consolidation

Centralizing the cases reduces the duplicative discovery and avoids conflicting rulings from different judges. Following pretrial proceedings and a series of test trials, known as “bellwether trials”, if the parties fail to reach testosterone settlement, the individual claims may be remanded back to the U.S. District Courts for separate trials.

Testosterone Therapy Litigation

There are more than 50 Testosterone Therapy product liability lawsuits filed in U.S. District Courts.  Injured men have alleged that they suffered a heart attack, stroke, and blood clots such as deep vein thrombosis and pulmonary embolism, caused by side effects of testosterone replacement therapy (TRT).

The majority of the lawsuits involve injury from the use of Androgel. The remainder have been filed by users of different testosterone gels, creams and patches, including Testim, Axiron, and Androderm.

Rafael Barrios requested that one centralized proceeding be established for claims involving all different manufacturers of testosterone replacement therapy (TRT). Barrios claims that his injury occurred following use of both Androgel and Testim, which are two different products made by different drug makers.

JPML Androgel Hearing

According to the U.S. JPML, the motion to establish an Androgel MDL will be heard on May 29 in Chicago. The second motion to include all testosterone lawsuits as part of a single MDL maybe be considered at that time, or the motion maybe be heard in July 2014.

Plaintiffs Testosterone Injury Claims

At least 37 of the lawsuits involve Androgel injuries. The claims involve allegations that the drug makers failed to adequately warn about the risk of heart attacks, strokes, blood clots and death associated with TRT.

Low Testosterone Medical Studies

In January 2014, according to a study published in the medical journal PLOSOne, low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65.

According to a November 2013 study published in the Journal of the American Medical Association, side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

FDA Launches Investigation

The FDA launched a safety review of AndroGel and other testosterone replacement therapy on January 31.

Direct to Consumer Aggressive Marketing

The complaints claim that the drug makers created the “disease” of low testosterone among men, blaming normal symptoms of aging on “Low T.”

 

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A Louisiana man, who suffered a deadly heart attack, filed a wrongful death lawsuit against Testim gel manufacturer. The lawsuit claims that the 61 year old died as a result of Testim testosterone replacement therapy side effects.

Androgel Stroke and Heart Attack AttorneyThe lawsuit was filed by the family of John Peuler against Auxilium Pharmaceuticals, Inc. on March 21, in the U.S. District Court for the Eastern District of Louisiana. There are close to 100 similar testosterone replacement therapy lawsuits filed across the United States in recent months.

What is Testim?

Testim gel is a popular prescription medication for men suffering from documented testosterone deficiency. Similar testosterone therapy drugs such as AndroGel, AndroDerm, Axiron and others, have achieved blockbuster sales with annual receipts exceeding $2 billion recently.

What is the Problem with Testosterone Replacement Therapy?

According to experts, Testim gel side effects and other testosterone replacement therapy treatments may increase men’s risk of suffering a heart attack, stroke, blood clots and sudden death. The plaintiffs have similar allegations that the testosterone therapy makers have failed to adequately warn patients and the doctors about the potential testosterone treatment risks.

Louisiana Plaintiff Allegations

According to the plaintiffs allegations, the man began using Testim testosterone gel for about a year, and had no past medical history of significant heart problems before using the gel.

Testim gel is alleged to be defective and unreasonably dangerous, and that Auxilium, the drug manufacturer participated in aggressive marketing campaigns that misrepresented the safety of the testosterone gel.

Testosterone Heart Concerns

The FDA has approved Testim gel and other testosterone medications for the treatment of low testosterone levels caused by hypogonadism. Hypogonadism is a rare medical disease that affects about 1 million men in the U.S. Unfortunately the medications are prescribed to millions of American men. According to some experts, Auxilium and others have created a fake disease, which encourage men to take testosterone supplements, to combat the normal aging process.

Testosterone Heart Side Effect Medical Studies

A recent study in the Journal of the American Medical Association(JAMA) reported that testosterone medications were associated with increased risks of heart attacks, strokes and death among older men with pre-existing heart disease.

Another medical study in the medical journal PLoSOne reported that testosterone drugs may double the risk of heart attack for young men with heart disease as well as for men age 65 and older who had no prior heart problems.

FDA Warning and Investigation

Hot on the heels of those two negative medical reports, the FDA on January 31announced that it has launched an investigation into the heart safety of testosterone therapy.

In March, Public Citizen a national drug consumer watchdog, called for a Black Box warning on all testosterone products warning men to the risk of heart attacks and strokes.

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Recently a Texas woman has filed a product liability lawsuit against Benicar drug manufacturer. The plaintiff alleged that Benicar side effects caused her to suffer chronic diarrhea problems, and severe weight loss.

texas dangeous drug attorneyHarriet Rubin, and her husband Allen, filed their complaint in the Superior Court of New Jersey. Benicar manufacturer Daiichi Sankyo removed the case to the U.S. District Court for the District of New Jersey on March 14.

There are several Benicar lawsuits pending in New Jersey, all of them have similar allegations that Daiichi Sankyo failed to adequately research their popular blood pressure medication or provide warnings for patients and doctors about the connection between Benicar and diarrhea intestinal disease known as sprue-like enteropathy.

Plaintiff Benicar Injuries

Rubin claimed that she developed sprue-like enteropathy, lymphocytic colitis, microscopic colitis, resulting in severe gastrointestinal problems, malnutrition and dehydration.

Plaintiff Lawsuit Allegations

Rubin filed against Daiichi Sankyo and its partners for designing a defective product, failure to warn, strict liability, negligence, negligent misrepresentation, fraud, breach of warranty, unjust enrichment and violating New Jersey consumer protection laws.

The complaint alleges that Daiichi Sankyo knew or should have known about the risk of Benicar diarrhea problems and sprue-like enteropathy, but failed to disclose the risk until after other medical studies were released and the FDA warning in 2013.

FDA Benicar Sprue-Like Enteropathy Warning

In July 2013, the FDA issued a drug safety communication informing about the association between Benicar and sprue-like enteropathy, an intestinal disease complex associated with chronic diarrhea, weight gain and malnutrition.

According to the FDA warning, patients may develop chronic diarrhea symptoms that can occur months or even years after the use of the popular blood pressure medication. In vast majority of cases, the diarrhea and intestinal symptoms usually stop when the medication is discontinued. But in serious cases, many patients have reported suffering extended periods of diarrhea that damage the intestines.

Mayo Medical Study

In 2012, a Mayo Clinic medical study, reported 22 cases of Benicar patients suffering symptoms similar to Celiac disease. Celiac disease is a severe small intestinal disease. This Mayo study was the first to raise public awareness of the potential side effects associated with Benicar.

What is Benicar?

Benicar is a popular angiotensin II receptor blockers (ARBs) medication, approved for the treatment of high blood pressure. There were an estimated 10.6 million prescriptions for Benicar or Benicar HCT in 2012.

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According to the latest medical research, the blockbuster erectile dysfunction drug Viagra may significantly increase men’s risk of developing melanoma. Melanoma is a lethal form of skin cancer, if not treated early.

texas dangeous drug attorneyViagra Medical Study: 84% Risk Increase in Melanoma

Boston researchers, found that men taking Viagra were up to 84% more likely to be diagnosed with the skin cancer when compared to men who do not use the drug. It is postulated that Viagra has a direct effect on the body’s ability to combat skin cancer.

Viagra Side Effect on Key Protein

JAMA medical journal published the study on April 7. Viagra, active chemical sildenafil citrate, reduces levels of a cancer-fighting protein called PDE5A. Reduction in PDE5A, increases the invasiveness of melanoma cells.

Viagra Cancer Mechanism

Sildenafil citrate (Viagra) is a phosphodiesterase (PDE) 5A inhibitor commonly used for erectile dysfunction. Recent studies have shown that BRAF activation down-regulates PDE5A levels, and low PDE5A expression by BRAF activation or sildenafil use increases the invasiveness of melanoma cells, which raises the possible adverse effect of sildenafil use on melanoma risk.

Study Involved Almost 26,000 Men

The study involved 25,848 men with an average age of 65, and analyzed the incidence of skin cancers including melanoma, squamous cell carcinoma, and basal cell carcinoma. About six percent of the men had used Viagra.

Skin cancers squamous cell carcinoma, and basal cell carcinoma risk did not increase. But, the risk of melanoma from Viagra appeared to increase 84%.

The study does not show a causal link between Viagra and melanoma, and researchers indicate that there needs to be more research before men should be warned away from the drug.

According to the study doctors, “Sildenafil use may be associated with an increased risk of developing melanoma. Although this study is insufficient to alter clinical recommendations, we support a need for continued investigation of this association.”

Pfizer Viagra Blockbuster Drug

Viagra (sildenafil citrate) was approved in 1998 and is manufactured by Pfizer. Viagra has been prescribed for over 22 million men since its initial approval by the FDA in March 1998. Pfizer, promotes Viagra as a treatment for erectile dysfunction and as a treatment for pulmonary arterial hypertension.

According to the American Cancer Society, melanoma is diagnosed in about 69,000 Americans each year and causes about 8,650 deaths annually.

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The jury in federal court in Louisiana, sent a loud and clear message on Monday, in rendering a bombshell verdict. Takeda Pharmaceutical Co. and Eli Lilly & Co.  were ordered to pay a combined $9 billion in punitive damages. The federal court jury found they hid the cancer risks of their Actos diabetes drug in the first federal U.S. trial.
https://www.youtube.com/watch?v=G4ItYan1QWo&feature=player_detailpage
Takeda, Lilly $9 Billion Punitive DamagesTakeda, based in Osaka, Japan, was ordered to pay $6 billion by the jury yesterday in Lafayette, Louisiana. Indianapolis-based Eli Lilly, Takeda’s partner, was ordered to pay $3 billion. Punitive damages are awarded in these types of cases to punish the companies for their wrongful acts.

The jury earlier awarded $1.5 million in compensatory damages to Allen, who blamed the drug for his cancer. Takeda, Asia’s largest drugmaker, is exposed to more than 2,700 Actos suits have been consolidated before U.S. District Judge Rebecca Doherty in Louisiana.

Punitive Award to be Appealed

The $9 billion jury award, the seventh-largest in U.S. history according to Bloomberg, is certain to be reduced because the U.S. Supreme Court has said punitive verdicts must be proportional to the awards of compensatory, or actual, damages.

Plaintiff Allegations

Allen sued both Takeda and Eli Lilly over Actos. Allen alleged in the Louisiana case that he developed bladder cancer after taking Actos for more than five years. Lilly served as Takeda’s U.S. partner in selling and marketing the drug over a seven-year period. According to court documents, Takeda agreed to indemnify Lilly for any personal injury liability associated with Actos. As a result, Takeda will probably bear the brunt of the final punitive and compensatory damages amount.

Actos Bladder Cancer Trials

The Louisiana trial is the fourth trial to hear allegations that Takeda marketed Actos knowing it could cause bladder cancer and failed to properly warn doctors and patients about the risks. Takeda and Lilly face hundreds more claims over Actos in state courts including Nevada and Illinois.

Lawyers in an Actos case that began in state court in Las Vegas in February have said they are seeking more than $1 billion in compensatory and punitive damages for two women who blame the drug for their bladder cancers.

FDA Mislead

Allen alleged in his lawsuit that Takeda ignored concerns about the drug’s cancer-causing potential and misled FDA regulators about its risks to protect billions in sales. Takeda didn’t provide a specific warning about Actos’ cancer risks until 2011, seven years after experts said the bladder-cancer link became clear and 12 years after the drug went on the U.S. market.

Court testimony revealed that Takeda officials intentionally destroyed documents about the development, marking and sales of Actos.

Documents Lost or Destroyed

Because Takeda failed to properly protect the Actos documents, the court allowed  jurors to infer that the files may have supported Allen’s claims that the company wrongfully hid the Actos bladder cancer risks.

After deliberating for about four hours, jurors found Takeda and Lilly “failed to adequately warn” about Actos’ bladder-cancer risks and that the drug caused Allen’s disease.

Jurors also found Takeda and Lilly executives “acted with wanton and reckless disregard” for patients’ safety in their handling of the drug and that justified a punitive damage award against both companies.

The consolidated Actos cases in Louisiana are In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299. Allen’s case is Allen v. Takeda Pharmaceuticals North America Inc., 12-cv-00064, both in U.S. District Court, Western District of Louisiana (Lafayette).

 

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Johnson & Johnson and its subsidiary Janssen Pharmaceuticals have agreed to settle Topamax birth defect lawsuits. Plaintiffs alleged that Topamax epilepsy drug side effects birth defects including cleft lips, cleft palates and other congenital malformations.

texas dangeous drug attorneyThe Topamax global settlements were announced last week in Pennsylvania state court, stating that agreements have been reached in 76 complaints. According to a report, the drug manufacturers are exposed to face at least 60 additional cases that are centralized in Philadelphia.

State Court Bellwether Trials

Three “bellwether” trials were held in the Philadelphia County Court of Common Pleas, which each resulted in a multi-million dollar damage award against Johnson & Johnson and Janssen. The plaintiff verdicts paved the way for a global settlement.

In October 2013, a jury awarded $4 million to the family of Blake Czimmer, who was born with numerous birth defects. In November 2013, a jury awarded $11 million to the family of Brayden Powell, who was born with a cleft lip and other deformities that may require five surgeries to fix. In March 2014, the family of a five year old boy was awarded $3 million for Topamax birth defects.

Another case in March was settled during the trial for a confidential sum.

Topamax Birth Defect History

Topamax was approved by the FDA in 1997, and it has been available as a generic since 2006. It is approved for the treatment of epilepsy, and migraines.

In March 2011, the FDA issued a warning about the Topamax oral cleft birth defect risk among babies born to mothers who took the drug during the first trimester of pregnancy. The FDA has urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy.

What is Cleft Lip and Cleft Palate?

Cleft palate and cleft lip occur when parts of the lip or palate fail to completely join together. The defect results are variable, in mild cases the child is born a notched lip and in extreme defects as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating, swallowing, speech and result in the need for corrective surgery.

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DePuy Orthopaedics is exposed to several thousand DePuy Pinnacle hip lawsuits, which allege defective metal hip design and early failure of the implant. The first federal bellwether trials for the metal-on-metal hip replacement system are set to begin in September 2014, in the Northern District of Texas in Dallas.

Amost 6,000 DePuy Pinnacle Lawsuits

According to the court case list, there are 5,879 defective hip product liability lawsuits pending in the federal court system involving the DePuy metal-on-metal Pinnacle hip.

Texas Federal MDL Consolidation

All of the federal cases have been consolidated as part of a federal multidistrict litigation (MDL). The lawsuits are centralized before U.S. District Judge Ed Kinkeade in the Northern District of Texas for coordinated pretrial proceedings and a series of early trial dates, known as “bellwether” cases.

Metal-on-Metal Hip Litigation

Over the past ten years, many similar metal-on-metal hip implants were released by different orthopedic manufacturers. These hip replacements have a metal femoral head that moves within a metal acetabular cup. The lawsuits involve allegations the that metal-on-metal hip implants are unreasonably dangerous and defective. Furthermore, the implants have  an increased risk of failure within a few years, because the metal parts grind against each other and release metal debris into the body. This causes elevated cobalt and chromium blood levels, also known as metallosis.

Johnson and Johnson DePuy ASR Multi Billion Settlement

Johnson & Johnson announced a DePuy ASR hip implant settlement in November 2013. The orthopedic divison agreed to pay at least $2.5 billion to settle more than 8,000 lawsuits over DePuy ASR hip replacements. The DePuy ASR hip implant is also a metal-on-metal design that is “substantially equivalent” to the Pinnacle hip.

DePuy Pinnacle Hip System 510(k) Approval

The DePuy Pinnacle hip system was released in 2001. The metal-on-metal system was used as the basis for the approval of the DePuy ASR hip implant in 2005. Johnson & Johnson obtained FDA “fast track” 510k status by claiming that the DePuy ASR and DePuy Pinnacle metal-on-metal hips were of “substantially similar” designs.

The DePuy Pinnacle was also approved under the FDA’s 510k approval process as a substantial equivalent to older metal hips. This fast track rubber stamping approval process, has allowed hip implants to be placed in thousands of unsuspecting patients without federal oversight. As a result no meaningful clinical trials have taken place to examine the safety of the design.

Over the years, a higher-than-expected number of patients were experiencing eaarly failure problems, and a DePuy ASR recall was announced in August 2010. Some experts called for a DePuy Pinnacle hip recall as well, but the implant was allowed to remain on the market.

Metal on Metal Hip Failures

More than 1,000 hip lawsuits have been filed over the Biomet Magnum metal-on-metal implants . In February 2014, a Biomet Magnum settlement agreement was announced, the manufacturer agreed to pay $56 million to resolve claims brought by patients who required revision of their hip due to early hip failure and metallosis problems.

DePuy Pinnacle Bellwether Trials

In the Pinnacle MDL, some cases are being presented for early trial dates, known as bellwether test trials. These bellwether cases are designed to gauge how juries respond to evidence and testimony in the trials.

Following these trial dates, if a DePuy Pinnacle settlement agreement is not reached, Judge Kinkeade will remand the cases to U.S. District Courts throughout the country for individual trial dates.