News Blog

3 More Stryker Hip Lawsuits Settled After Mediation

September 2nd, 2014

Three Stryker lawsuits filed on behalf of those who suffered serious complications caused by the Rejuvenate Hip Stem and the ABG II Modular Hip Stem have completed mediation and two have been settled, according to the Long Island News. This brings the number of New Jersey Multicounty Litigation (MCL) cases mediated up to 21 and the number of mediated cases resolved to 19. Others are still pending in the Stryker Hip Implant MDL and have been set for trial in the Summer of 2015. It is expected these cases will help expose the inadequate pre-marketing testing and derive top dollar for those affected by these defective implants.

The lawsuits allege that Stryker’s metal on metal hip implant products cause serious side effects including metal toxicity and device failure, according to court documents. In December 2013, Stryker agreed to settle four other hip lawsuits filed in New Jersey state court for undisclosed sums. Stryker has reportedly set aside between &700 million and $1.1 billion for litigation expenses, according to the Wall Street Journal.

Stryker Hip Implant Recallstryker

Stryker decided to voluntarily recall its Rejuvenate and ABG II hip stems in June 2012 due to prospective fretting and corrosion at the modular-neck junction that could potentially result in adverse local tissue reactions (ALTR) as well as pain and/or swelling at or around the hip.

After the recall, Stryker recommended that surgeons consider performing blood work and cross section imaging on all patients who received a Rejuvenate or ABG II modular-neck hip stem, even in the presence of normal findings and regardless of whether the patient is experiencing pain and/or swelling.

Costs to Stryker

According to Stryker, the ultimate total cost to resolve the entire matter is still uncertain and will depend on the number of and actual costs of patients seeking testing and treatment services, the number of and actual costs of patients requiring revision surgeries, the number of and actual costs to settle lawsuits, and the amount of third-party insurance recoveries. Stryker is reimbursing patients for testing, treatment, revision surgery if necessary, and other costs related to the recall via a company called Broadspire. Read our previous post on Broadspire before you reach out to them as there are some important things you need to know about them.

Patients-Suing-Over-Recalled-Stryker-Hip-Implant Approximately 20,000 of the Stryker devices have been implanted in the U.S., and more than 3,000 lawsuits have been filed over damages caused by the hip implants. Stryker hip implant recall lawsuits continue to be filed by those affected by these dangerous products and the law firm of Childers, Schlueter & Smith continue to review and file the same. If you have questions about your potential hip implant claim, give us a call to learn how we can help.

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Ortho Implant Recall Site Seeks To Register Implants And Promote Patient Safety

August 28th, 2014

We are pleased to inform everyone there is now an organized and physician backed Joint Registry for those with hip, knee and shoulder implants: www.orthoimplantsite.com

Ortho Implant Site

The registry site is the first of its kind to promote awareness and information on joint recalls, issues and potential solutions for patients. It is also designed to help track all hip, knee and shoulder implants which, unbeknownst to most, is currently not required of implant manufacturers by the FDA.

Per the Ortho Implant Recall Site:

If you or a loved one has had hip, knee, shoulder or any kind of joint replacement surgery, the Ortho Implant Recall website is your resource to find out whether or not your implant has been recalled for any reason. Please join our registry and you can rest easy knowing that if the FDA issues a recall or if there is an industry recall on your replacement joint, you will be notified quickly. Your physician has no obligation to notify you so please take advantage of the Ortho Implant Recall registry and join today.

Ortho Implant Site-Why Join

Given all the medical device recalls and claims we have seen over the years, we are happy to see a caring group organize this needed joint registry. We hope it will promote a more informed patient experience and lead to more timely treatment regime if and when needed.

 

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Why Parking Lots are Fertile Ground for Accidents

August 27th, 2014

Parking lots are unique places where those frequenting them have likely been both a hurried driver and a distracted pedestrian at one time or another. There’s a lot going on in a parking lot: cars coming and going, drivers pulling in and out of parking spaces, pedestrians walking to and from business establishments, sometimes in the path of oncoming vehicles.

Although cars typically move more slowly in parking lots, drivers are also distracted (looking for that perfect spot, no doubt), traveling unpredictably in all directions, weaving back and forth, and generally putting other motorists and pedestrians at risk. Not surprisingly, the Washington Post reports that more than one in five motor vehicle accidents occur in parking lots.

Parking Lot Accident Procedure

If you’re involved in a parking lot accident, either as a motorist or pedestrian, there are certain steps you should take as soon as possible:

  • Remove the cars from the accident scene into a safer location, or if they cannot be moved, turn on your emergency flashers and exit the vehicle.
  • Check for injuries, and call for medical assistance if necessary.
  • Call the police and your insurance company to report the accident.
  • Exchange contact and insurance information with the other party involved.
  • Note the time, date, location, weather conditions, parking lot conditions, and another other important details.
  • Take pictures of the scene, the damage, and the injuries sustained if possible.
  • Get the names and phone numbers of any witnesses to the accident.
  • If you or someone else has been seriously injured, consider speaking with an accident attorney.

Fault in Parking Lot Accidents

Establishing fault in a parking lot accident can be extremely challenging, and for this reason, if you are injured, calling an attorney might be advisable. Because parking lots are typically on private property where the rules of the road don’t apply, the police might not investigate or complete a report on a parking lot accident. It generally comes down to one person’s word against the other, and insurance companies usually split the fault equally, regardless of who may have actually been to blame.

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Johnson & Johnson Wants Baby Powder Lawsuit Dismissed

August 26th, 2014

Johnson & Johnson is requesting that a federal judge dismiss a class action lawsuit that alleges that the talcum-based product may increase the risk of ovarian cancer in those who use it in their genital areas.

The suit, filed by Barbara Mihalich, is seeking class action status for all consumers in Illinois who purchased Johnson’s Baby Powder, and alleges that the company failed to disclose that the talc may put women at a 33 percent increased risk for ovarian cancer. According to J&J, the plaintiff does not have ovarian cancer, did not use the product on her genitals, and shows no damages in her claim.

The Link between Talc and Ovarian Cancer

Several studies have found that the use of talcum powder on a woman’s genital area may significantly increase their risk of ovarian cancer because it may migrate from the vagina into the fallopian tubes, uterus, and ovaries. One study, published in the medical journal Cancer Prevention Research in 2013, found that women who use talc on their genital areas may have a 20 – 30 percent higher risk of ovarian cancer than those who do not.

According to cancer.org, it is not clear if talcum powder use increases cancer risk, but until more information becomes available, the American Cancer Society is recommending that women who are concerned might want to limit their use and consider cornstarch-based products instead.

In October 2013, a South Dakota jury determined that J&J failed to adequately warn consumers about the risk of ovarian cancer from talcum powder in a product liability lawsuit brought by a woman who developed ovarian cancer in 2006 after using Shower to Shower body powder for 30 years. Harvard University doctor Daniel Cramer, who has been studying the link between talc and ovarian cancer for three decades, testified in the case that talcum powder “probably caused 10,000 cases of ovarian cancer every year.”

New cases and causes of action are being investigated now on an individual basis for those who have developed ovarian cancer after prolonged use of Talc. If you have questions about your legal rights we are here to help.

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Cubist Pharmaceuticals Recalls 100+ Lots of Cubicin

August 19th, 2014

One hundred and one production lots of the antibiotic Cubicin, the intravenously administered prescription used for the treatment of skin and bloodstream infections, was voluntarily recalled by Cubist Pharmaceuticals on August 6 due to the potential presence of glass particles in vials produced by a contract manufacturer.

When a glass particulate is present in an intravenous drug, patients are potentially at risk for the following:

  • Thromboembolism
  • Life-threatening pulmonary emboli
  • Phlebitis
  • Mechanical block of the capillaries
  • The formation of granulomas, a protective local inflammatory response to foreign material

According to the FDA, patients with a preexisting condition of trauma or another condition that affects the microvascular blood supply are at an increased safety risk.

What is Cubicin?

Cubicin is used to treat bacterial infections of the skin and underlying tissues. It is packaged in single-use vials and distributed nationwide. Common side effects include:

  • Nausea
  • Vomiting
  • Constipation
  • Diarrhea
  • Headache
  • Dizziness
  • Trouble sleeping
  • Anxiety
  • Pain, redness, and swelling at the injection site

Cubist is notifying customers of the recall by letter and telephone, and anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots and discontinue use and arrange for return and replacement of the affected lots. The company is expecting to recall about 50,000 vials of Cubicin that were manufactured between November 2011 and February 2014.

This is the third recall in 12 months for the Lexington, Massachusetts-based drug maker, although the previous two were on a much smaller scale, they also involved supplier issues. In each instance, the presence of glass particles triggered the recall. Like the previous two, this recall is precautionary, as no complaints of trace glass particles in vials or any adverse effects associated with the product have been reported to date.

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More Oversight Is Needed To Hold Careless Drugmakers Accountable

August 19th, 2014

At long last, the Food and Drug Administration and our nation’s Congress are beginning to see how important quality control in drug manufacturing facilities is to public health and safety, something we’ve understood at Childers, Schlueter & Smith for quite some time. The FDA is launching a new regimen of quality-control initiatives aimed at overseas drug manufacturing, potentially empowering former and current victims of drug companies with sloppy production techniques.

Because the U.S. imports so many drugs and pharmaceutical ingredients at this point, the FDA now realizes that the demanding standards they place on U.S. production facilities are going to have to be employed elsewhere as well in order to truly protect the American public. About 40 percent of drugs consumed in the U.S. are shipped from abroad, and 80 percent of active ingredient makers are located outside the U.S., according to FDA reports. You can imagine what that means for the scope of the new policies.

FDA officials just launched a pilot project that loosens import restrictions for those drugmakers that the agency respects, freeing up inspectors to focus on less reliable companies. The FDA said its India drug inspection workforce will grow to from 3 positions to 10. There are also plans to create a central U.S. office dedicated to pharmaceutical quality.

Concerns that U.S. regulators were ill-equipped to police globalized drug manufacturing have been simmering for some time. A wake-up call came in 2008 when more than 50 people died after using Baxter Healthcare Corp.’s blood thinner heparin which the FDA found had been contaminated with ingredients made in China.

The flood of new initiatives goes hand in hand with an intense interest from the U.S. Department of Justice in pursuing civil and criminal cases against messy manufacturers. Early last year, one official from the department vowed to take an especially hard look at breaches of good manufacturing practices and bring those companies not up to par to justice. The FDA and Congress have begun to hold drugmakers liable for every step of the supply chain, where multiple companies often play a role in creating a single product. Last year, an important guidance document about contract manufacturing made clear that both drugmakers and their contractors are responsible for ensuring quality.

There is no question that Congress is pushing both the FDA and the Department of Justice to criminally prosecute people in the pharmaceutical industry who do not follow the law. Congress has come to the conclusion that civil fines are no longer effective when up against a massive drug conglomerate.

It’s possible that the additional FDA inspections will lead to more recalls, which can fuel investor suits as well as personal injury suits. Last year, for example, Johnson & Johnson paid $23 million to end a shareholder complaint over an alleged cover-up of production errors linked to a massive recall of medicine.

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M. Brandon Smith Listed In 2015 Best Lawyers® Edition

August 18th, 2014

Childers, Schlueter & Smith L.L.C. is proud to announce that firm partner M. Brandon Smith has been listed in the  2015 Edition of  Best Lawyers® In America. Best Lawyers® is the oldest and most respected peer-review publication in the legal profession. A listing in Best Lawyers® is widely regarded by both clients and legal professionals as a significant honor, conferred on a lawyer by his or her peers. For more than three decades, Best Lawyers® lists have earned the respect of the profession, the media, and the public, as the most reliable, unbiased source of legal referrals anywhere. Its lists of outstanding attorneys are compiled by conducting exhaustive peer-review surveys in which tens of thousands of leading lawyers confidentially evaluate their professional peers.

Smith-Best Lawyers 2015

“It is a great honor just to be nominated in Best Lawyers®, much less make the final selection list. I am very fortunate to have such a great office and family-without them both, none of this would be possible. I am therefore very humbled by this recognition,” says M. Brandon Smith.

Although very appreciative, Mr. Smith is not alone in terms of awards and honors bestowed upon him. The lawyers and team members at Childers, Schlueter & Smith L.L.C. continue to be recognized for their tireless work and efforts on behalf of consumers all over the Country.  With other designations and recognitions in 2014 such as: Super Lawyers, Top 100 Lawyers, Top Lawyers 40 Under 40, Elite Lawyers of America; CSS Firm continues to strive for the highest level of client satisfaction and results. With over $300,000,000 recovered in verdicts and settlements thus far, they certainly appear to be on the right track for both.

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Pfizer Pays $35 Million in Rapamune Settlements

August 18th, 2014

According to the Associated Press, Pfizer plans to pay $35 million to resolve allegations by 42 states that its subsidiary, Wyeth Pharmaceuticals, illegally marketed an organ transplant drug for unapproved uses.

The states’ attorneys general said on August 6, 2014 that Wyeth, which New York-based Pfizer acquired for $68 billion in 2009, trained sales representatives to encourage doctors to prescribe Rapamune for uses other than preventing rejection of transplanted kidneys. Rapamune was approved by the Food and Drug Administration in 1999 only for use in kidney transplant patients, and promoting drugs for uses not cleared by the FDA is illegal.

Rapamune (generic name sirolimus) lowers a person’s immune system to prevent the rejection of a transplanted kidney. It can also lower blood cells that help a body fight infections, making it easier for an individual to bleed excessively from an injury or get sick from being around others who are ill.

Other potential side effects include joint pain, nausea, vomiting, diarrhea, constipation, stomach pain, headache, acne, and skin rash.

Under the terms of the settlement agreement, Pfizer will reform its marketing and promotional practices to avoid unlawfully promoting Rapamune or any Pfizer product, and will not:

  • Make false, misleading, or deceptive claims
  • Make any claim comparing the safety or efficacy of a Pfizer product to another product when that claim is not supported by substantial evidence
  • Promote any Pfizer product for uses not approved by the US Food and Drug Administration
  • Provide incentives to encourage sales for off-label uses
  • Seek to have Rapamune included in hospital protocols or standing orders unless it is to be used for an FDA-approved purpose
  • Share information describing any off-label or unapproved use of Rapamune unless such information complies with FDA regulations
  • Seek to influence the prescribing of Rapamune in hospitals or transplant centers in any manner that does not comply with federal law banning kick-backs, including through funding clinical trials

Pfizer said in a statement that the alleged illegal activity occurred before it acquired Wyeth, and did not admit any wrongdoing or liability as part of the settlement. The company agreed to pay nearly $491 million in July 2013 to resolve a similar investigation by the Department of Justice.

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RegenESlim Recalled Due to Presence of DMAA

August 15th, 2014

Regeneca Worldwide, a division of VivaCeuticals, Inc. in Las Vegas, is voluntarily recalling its RegenESlim appetite control dietary supplement due to the confirmed presence of DMAA in certain lots of the supplement. DMAA, also known as dimethylamylamine, methylhexanamine, or geranium oil/extract, is typically used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.

The FDA has warned that DMAA is dangerous because it can narrow blood vessels and arteries and cause a corresponding rise in blood pressure or other cardiovascular problems, such as:

  • Shortness of breath
  • Arrhythmias
  • Elevated blood pressure
  • Tightening in the chest
  • Heart attack
  • Death

Until 2012, DMAA, which was first discovered by Eli Lilly and Company in 1944, was sold by numerous companies. It was marketed as the nasal decongestant Forthane until 1983, and reappeared as a dietary supplement in 2006. The FDA reported that by April 2013, it had received 86 adverse event reports from people who used DMAA, and in response sent warning letters to a total of 11 companies advising them that DMAA-containing products marketed as dietary supplements are illegal and must be taken off the market. These companies include:

  • Exclusive Supplements – Biorhythm SSIN Juice
  • Fahrenheit Nutrition – Lean Efx
  • Gaspari Nutrition – Spirodex
  • iSatori Global Technologies, LLC – PWR
  • Muscle Warfare, Inc. – Napalm
  • MuscleMeds Performance Technologies – Code Red
  • Nutrex Research – Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, Lipo-6 Black Hers
  • Regeneca, Inc. – RegeneSlim
  • SEI Pharmaceuticals – MethylHex 4,2
  • SNI LLC – Nitric Blast
  • USP Labs, LLC – Oxy Elite Pro, Jack3D

Although there have been no reported illnesses to date, the voluntary recall was the result of FDA analysis confirming the presence of DMAA in RegenESlim. Regeneca Worldwide is conducting a continuing investigation on the problem.

Customers who have purchased RegenESlim Lot #EX0616R15814 and Lot #11414RE5516 are advised to stop using the product immediately and return it to the place of purchase for a full refund. Adverse reactions to the supplement may be reported to the FDA’s MedWatch Adverse Event Reporting program online, fax, or via regular mail.

RegenESlim is purchased by and distributed through direct sales in the U.S. and Puerto Rico, and also through online sales for both personal use and retail sales.

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Xarelto Lawsuit Filed Over Bleeding Risks And Injuries

August 13th, 2014

Virginia Stuntebeck sued Johnson & Johnson and Bayer AG in Pennsylvania Court earlier this year, alleging that she suffered severe internal bleeding stemming from use of the blood-thinning drug Xarelto. In the Xarelto lawsuit, which appears to be the first tort suit filed over the medication in Philadelphia, Stuntebeck said the drug should not be sold because of the high risks surrounding its use.

Xarelto-pill_MainStuntebeck confessed that she was hospitalized in February 2013 for severe internal and gastrointestinal bleeding as a result of using the drug. As the manufacturers and distributors of Xarelto, Johnson & Johnson knew or should have known that Xarelto use was associated with irreversible bleeds. Stuntebeck’s lawsuit claims the warning label on Xarelto fails to properly convey the true risks of the drug as it relates to uncontrolled bleeding events and other serious injuries including death.

Xarelto is now being likened to its competitor Pradaxa which is the subject of more than 2,000 injury lawsuits in a multidistrict litigation and occasionally referred to as “the most complained about drug” in the U.S.

Both Pradaxa and Xarelto claim in their marketing that you don’t need to monitor a patient taking the drug to prevent blood clots and stroke. This is supposedly an advantage of these blood thinners since the more well-established anticoagulant warfarin (Coumadin) frequently requires medical monitoring and doctor supervision.

28367The U.S. Food and Drug Administration originally approved Xarelto in July 2011 to reduce the risk of blood clots and pulmonary embolism. They extended the recommendation to include the treatment of abnormal heart rhythm or a-Fib which leads to strokes later that same year. But the subsequent approval was against the recommendation of FDA staff who noted serious safety concerns with Xarelto. Recently, the FDA has refused a third expansion of the Xarelto’s use.

At Childers, Schlueter and Smith LLC, we feel that drug manufacturers and medical professionals should be at fault when their treatments cause serious side effects and put people in danger. If you suffered internal bleeding event or some other injury as a result of Xarelto, you may have a legal claim.

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