U.S. Department of Justice Investigates Johnson & Johnson for Destroying Litigation Documents

Things have gotten so bad for J&J that the U.S. Department of Justice has started to investigate the troubled company for destruction of litigation documents. The tens of thousands of lost documents are substantial to injured women's claims. Johnson &Johnson's troubles are not just limited to the Department of Justice. A nonprofit group, Corporate Action Network, has requested that Attorney General Eric Holder also investigate Johnson & Johnson for crimes of obstructing justice and destroying litigation documents.

In civil trial court, the Honorable Judge Cheryl Eifert in West Virginia issued an Order that Johnson & Johnson had negligently destroyed or lost documents regarding the testing and complications for pelvic mesh implants.Millions of women have received transvaginal mesh implants to repair pelvic organ prolapse or stress urinary incontinence. This happens because of the lack of urethra support, which is often a consequence of damage to pelvic support structures from childbirth. Manufacturers such as Johnson & Johnson, American Medical Systems, Inc. (AMS), Boston Scientific Corp., Coloplast Corp., C.R. Bard, Inc., and multiple others, have been accused of poorly designing and testing these products.

More than 22,000 women have sued Johnson & Johnson for unbearable pain, infections, bleeding, and urinary problems. Victims of pelvic mesh implants allege that Johnson & Johnson executives knew that these implants were defective, but they didn't take any precautions and didn't give any warnings to the consumers. Now, many of these women are disabled with pain and unable of having an active life.

Five Boston Scientific Vaginal Mesh Cases Transferred to Florida
 

On April 11, 2014, Judge Joseph R. Goodwin, who presides over six vaginal mesh multidistrict litigations in West Virginia, ordered the consolidation of five Boston Scientific vaginal mesh lawsuits for trial next September. Originally, these actions were filed in the federal court of Florida. According to the current order, these cases will be transferred back to the U.S. District Court for the Southern District of Florida. The controversial trial will begin on September 29, 2014 and Judge Goodwin will supervise the consolidated cases via intercircuit assignment.

Overall, there are over 11,000 cases filed against Boston Scientific Corporation. In particular, this multidistrict litigation came to light from the use of transvaginal surgical mesh to treat pelvic organ prolapse ("POP") and stress urinary incontinence ("SUI"). The injured plaintiffs assert that the Pinnacle Pelvic Floor Repair Kit ("Pinnacle"), a mesh product of Boston Scientific Corporation and used to treat POP, caused them compensatory and punitive damages because of negligence, manufacturing defects, and failure by the company to warn physicians and consumers about the dangers of its device.

Judge Goodman explained in his Order that the predomination of common issues of law and fact favor the consolidation of the cases into one trial in Florida. Some factors include that the cases involve the same product, the parties are all Florida residents, suffered similar injuries, and underwent their surgeries in that state.

Injured Victims Voice Outrage Over Johnson & Johnson's Defective and Dangerous Products

Last week the annual shareholder meeting of Johnson & Johnson took place at its headquarters in New Brunswick, New Jersey. Despite the proclamation of approvals and initiation of some recent prescription medicines and medical devices, a large number of injured persons, especially from pelvic mesh implants, turned up at the company and expressed their disapprovals for J&J products. Their negligence has been so bad, that Corporate Action Network recently demanded Attorney General Eric Holder to investigate whether Johnson & Johnson deliberately destroyed the litigation documents pertaining to its Ethicon mesh devices.
 

Transvaginal mesh (sometimes referred to as vaginal sling, vaginal tape, or vaginal patch) is a medical device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). J&J has been sued by patients for their defective pelvic mesh implants, as these devices have reportedly caused them insuperable pain, infections, bleeding, and urinary problems. The protested crowd requested responsibility for their injuries due to the deficient vaginal mesh implants.

These harmed females suffer constantly and seek justice, alleging that J & J executives were aware that these implants were flawed, but they didn't take any preventive measures and didn't give any cautionary advice to their customers. Teresa Sawyer, a recently married woman from Ohio spoke about the J&J CEO Alex Gorsky and stated that he has hurt her because of her vaginal mesh surgery in 2011, which resulted in tremendous infections, strange immune conditions, and wrecking of her sex life. Sudden shock filled the press conference when Robert Fish from Florida mentioned that his mother, Darlene, committed suicide in 2011 because of the intolerable pain caused by mesh implant she had received in 2008. New updates will come up about this significant pending litigation, as we are in expectance of the Attorney General to decide whether or not he will initiate the investigation against J&J.

More Defective Medical Devices Harming Patients
 

Recent FDA recall statistics sadly confirm what we already know: more dangerous medical devices are flooding the market, some even killing patients. The FDA tried to justify the 97% increase in medical device recalls from 2003 to 2012, by alleging that the medical industry faces these problems both effectively and efficiently. Despite this meaningful and imminent concern, the FDA recorded nearly 1,200 recalls in 2012, 57 of which were Class I recalls (those that can provoke serious injury or even death).

The increase in Class I recalls has occurred because of the speedy trial and testing procedures of the FDA's Center for Devices. Janet Trunzo, AdvaMed Senior Executive Vice President for technology and regulatory affairs tried to explain the FDA's position. She explains that the FDA reports results by noting the rise of more complex medical devices now than a decade ago. Nevertheless, the complexity of the devices is not a significant factor for the increase of devices' recalls.

Furthermore, Dr. Robert Hauser, a prominent cardiologist casts doubt on the FDA report's conclusion, and crucified this by underlying the ineffectiveness of the FDA's regulatory system to prevent the defective devices' presentation on the market. He also emphasized the statistics' absence from the report regarding the torts to patients and the ensuing cost to our health system. According to FDA report, most of the medical devices are recalled due to problems associated with device design, software, and non-conforming material or component issues. Despite the facts that medical device industry and FDA try to implement and release on the market the most harmless medical devices for improvement of our lives, the recent data show that every year we face a huge increase of defective and unsafe medical devices, and as a consequence a great number of patients can be in darkness of these issues and mainly in great peril.

Ethicon Spoils Evidence in a Surgical Mesh Products' Litigation

On February 4th, 2014, Judge Goodwin ruled in favor of a Plaintiffs' motion for a finding of spoliation and sanctions in the multidistrict litigation against Ethicon Inc. regarding claims involving surgical mesh products. Ethicon, Inc. designed, manufactured, marketed, and sold these products to treat pelvic organ prolapse and stress urinary incontinence.

The Court decided in part that Ethicon destroyed or otherwise lost documents that should have been preserved in anticipation of litigation. Moreover, the Court explained through its order that Ethicon's loss of evidence was negligent and ordered compensation as monetary sanctions in favor of the Plaintiffs. The Court reasoned this decision with the additional time spent by Plaintiffs attorney placing together missing custodial files and preparing for depositions of key employees for whom insufficient information was furnished by Ethicon.

U.S. Stock Market & Investors Alleged to be Victimized by High-Frequency Traders
 

As technology has greatly evolved, modern practices and tricks have dominated the U.S. equity market. As a result, millions of investors have been exploited by high-speed predators. These fast traders utilize their advanced computers and software, in order to jump front the stock investors, get enhanced and advanced information on prices, detect what investors intend to buy, purchase it first and then try to sell it at a higher price. Some of the most well-known and largest high-speed traders are Virtu-Financial Inc., Bats Global Market Inc., and the Lexena, which has merged with Direct Edge Holdings Inc. Furthermore, Bloomberg LP furnishes its clients with significant proprietary exchange information. Specifically, reputable banks, financial institutions, and fast trading companies spend millions of dollars on services and products that will enable them primacy and exclusiveness in trade information.

These voracious acts and methods were noticed by Brad Katsuyama, a prior Canadian trader of the Royal Bank of Canada, who proved that high-speed predators perceive the market business by using specialized algorithms. This allows them to buy and sell stock in fractions of seconds before the market news become public. Despite the blurred legality of this issue, New York Attorney General Eric Schneiderman recently decided that an investigation should be initiated regarding the privileges marketed to professional traders, which allow them to set their computers close to exchanges and purchase access to faster data streams and voluminous information on trades.

In addition to that, the Securities and Exchange Commission and Commodity Futures Trading Commission bolster the viewpoint that the underlying market rules should be scrutinized closely because of the computerized trade exploitation. The Federal Bureau of Investigation will unveil at the end of their probe if high-speed trading firms violate U.S. laws by taking advantage of unpublished information over innocent investors of pension and retirement funds.

Under the Light of the Imminent Greek Elections

Under the stress of the financial crisis and political turmoil, Greece is ready again for elections. The Greek Municipal and Regional elections of 2014 are going to be held on May 18. The by-elections and the European elections will take place on May 25. The term of the office of the elected members will be from September 1, 2014 until August 31, 2019.

 

According to the underlying electoral process, along with the Greek voters of the Greek territory have the right to vote and the Greek citizens - residents of the 27 other EU countries. These results will be incorporated in the overall vote results in the Greek Territory. The Greek voter will need to present before the Electoral Commission during the vote her identity card or passport or driving license or an individual health card issued by any Greek insurance fund. As polling stations will be used buildings of the Greek embassies and consular buildings, other Greek authorities or departments, independent offices, Orthodox Greek Churches, Greek communities, associations or organizations. If the aforementioned buildings do not suffice to meet the needs of the procedure, it is possible to be used buildings or establishments of the Member State of the EU.
 

Unfortunately, the Greek citizens who do not reside in Greece or in a Member State of the European Union are not able to exercise their right to vote. The ambassadorial and consular authorities of Greece to the other Member States of the European Union have the duty to inform by any means Greeks voters residing in their region for their right to participate in elections to the European Parliament. Moreover, in order to exercise the right to vote in their place of residence, the Greek inhabitants abroad must fulfill the following requirements;

i. They must be registered in the electoral roll of a municipality in the Greek Territory.

ii. They have the right to vote and have not been denied this right.

iii. They must make a declaration to the relevant Ambassador or Consulate in the region of EU in which they intend to exercise their right to vote, that they wish to vote in their place of residence.

Until April 4, the Greek voters who reside in other Member States of the European Union were able to submit applications for the exercise of their right to vote in European elections. Although the first deadline was on March 28, the Ministry of the Interior in Greece decided to extend this. As it was noted in the No. 769/28.3.2014 decision, signed by the Minister of the Interior, Yiannis Michelakis; “the extension was such a relevant interest, which was observed with a view to ensure the widest possible participation of the Greek citizens in the upcoming elections of the members of the European Parliament”.

The controversial legal issue is why the Greek political system doesn’t change by permitting to the Greeks who work or reside in other countries or states other than Members States of the European Union to vote by postal vote, expressing in that way their political beliefs and exercising their rights. The matter has deeper roots, which are related to our hereditary political system and the uncontrolled and independent judgment of Greeks, who work or reside abroad. Maybe, our votes are not so predictable and simply data. Greece has taught the democracy and the freedom. What does the modern Greece do? Does Greece separate its citizens in two categories? Let’s hope that the impending elections will bring the redemption and the prosperity in our country.

Tremendous Public Anxiety for Spinal Cord Implants; Increase of Paralysis Incidents

New data finally came to light regarding the causes and the great number of paralyses to patients who have undergone a spine cord implant surgery. Most of the injuries have arisen after patients’ spinal cords were perforated or squeezed by the stimulator electrodes. Complications with SCS vary from reversible injuries to traumatic partial or permanent paralysis, nerve injury and death. 

According to the FDA’s recent facts and statistics, there was a high rise of paralysis reports in 2013 than the prior years. The paralyzed patients had received spinal cord stimulators by different companies, involving the Medtronic Inc., St. Jude Medical Inc., and Boston Scientific Corp. 

A spinal cord stimulator (SCS) is a mechanism emits pulsed electrical signals to the spinal cord to mitigate chronic pain. An SCS has significant analgesic properties and is used mostly in the treatment of failed back surgery syndrome, complex regional pain syndrome and refractory pain because of ischemia. Electrodes are implanted in the epidural space and an electrical pulse generator sends electrical pulses to the spinal cord. These pulses intervene in the nerve impulses that make someone feel pain.

The problem has a great deal of roots. Doctors who implant these devices are not properly trained about the whole procedure and they are not aware of the risks of operating near the spinal cord and the methods for alleviating the dangers. In addition, these poorly prepared surgeries are operated by a wide variety of physicians; anesthesiologists, neurosurgeons, and orthopedic surgeons. There are no skilled and specialized physicians to spinal cord implants. The companies have undertaken the doctors’ training by placing their representatives, non-physicians, to direct and instruct the real physicians, even during the operations. Companies are aware of the spinal cord stimulator procedures’ risks, but they delude themselves by believing that these implants are simple to operate. However, Mr. Greenwood’s paralysis after a spinal cord implant surgery in Dallas in 2012 and hundreds other paralysis’ events witness the truth regarding the accountability of these damages and the risks of spinal cord implants.

FDA Considers Rigid Protective Rules to Wipe out the Harm of Pelvic Mesh Implants’ Usage

 

FDA desires to enforce more scrupulous safety requirements for surgical mesh implants. This action verifies and underscores the high and developing anxiety over safety matters regarding these implants, which are used to cure women’s pelvic problems. FDA deliberates stricter rules for these defective implants because the governmental agency aims to the reallocation of pelvic mesh implants to a high risk category as a medical device rather than a moderate risk.
 

It is world known that Johnson & Johnson, the dominant manufacturer of these medical devices has been sued by more than 22,000 patients for their defective pelvic mesh implants. These devices have reportedly caused overwhelming pain, infections, bleeding, and urinary problems to injured women. FDA has analyzed and pinpointed the unambiguous risks of surgical mesh implants through immeasurable patients’ reports and will take drastic measures soon to eliminate the risks and put on market harmless and competent medical products. Specifically, FDA will initiate to ask manufacturers to apply for pre-market permissions to FDA in order the agency to assess the medical device’s invulnerability and efficiency before setting the product on the market.

Stryker Settles Through Mediation; More Cases are Expected to be Determined

Honorable Judge Brian Martinotti supervises in a multi-county litigation (MCL) in Bergen County, where more than half of the nearly 1,500 lawsuits have been filed against Stryker Orthopaedics ("Stryker"). Judge Martinotti recently strengthened the role of mediation, as a peaceful way of disputes' settlement, conflicts' prevention and resolution. Specifically, he called for mediation ten Stryker cases regarding lawsuits involving the product sold under the name of the Rejuvenate System, a metal-on-metal hip replacement system, which was recalled along with ABG II hip implants in July 2012, because of the crucial health problems that patients were experiencing.

 

One case was delayed, and out of the remaining nine, eight have been settled. Ten more cases are expected to be settled through this thriving process. A settlement through mediation can alleviate some of the pain and suffering, which patients suffer as they seek resolution to a traumatic and distressing hip problem. Fortunately, two Plaintiffs from our firm were selected to participate in this mediation process. Judge Martinotti will have a Case Management Conference on Tuesday April 1, 2014 where both Plaintiffs and Defense counsel will have an opportunity to discuss the status of the litigation and mediations.

 

It is well known that metal-on-metal hip implants can cause early failure and metallosis due to their allegedly flawed design and can cause patients severe hip/groin/leg pain, injury from metallic debris, infection, local swelling, tissue death, numbness, limp or changes in ability to walk which can result in a second revision surgery for the patient. More evidence regarding hip implants complications and failures shed light on these issues after DePuy, a subsidiary of Johnson & Johnson, evolved three hip replacement designs since 2000 with high failure rates. The problems with all three systems arise from their metal-on-metal parts, and the two ASR systems were recalled in mid-2010. Depuy has settled thousands of individual cases and conceded that the ASR systems were defective. In light of these significant matters, the Food & Drug Administration has ordered manufacturers for metal-on-metal products to conduct studies, testing and follow ups after the implants have been used in patients.