FDA Alerts Blog

Update: Stryker Rejuvenate and ABGII Hip Global Settlement Announced

November 3rd, 2014

Just over two years since the Stryker Rejuvenate and ABGII hip implant products were recalled from the market in June 2012, national leadership in the multi-district litigation (MDL) today announced a global settlement proposal for all Stryker Rejuvenate and ABGII hip implant victims who have undergone revision surgery to remove and replace their recalled Stryker hip implant on or before November 2, 2014.  The settlement proposal includes a base award amount of $300,000.00 to each claimant who has undergone revision surgery on or before to November 2, 2014, and otherwise qualifies for the settlement. There are certain limited potential reductions to the base award for age, prior hip revisions, and other relevant factors.  Claimants may also receive additional compensation, referred to in the proposed settlement as “Enhancements,” at a later date if they can demonstrate that they meet the eligibility requirements for the categories set forth in the settlement agreement.

Stryker-Rejuvenate-Hip-Replacement-Recall-Although participation is voluntary, it is expected that many of those that qualify (those who have had their recalled Stryker hip removed and replaced on or before November 2, 2014) will benefit from the settlement program, and may ultimately decide to participate in the settlement.  Any such decision should be made on an individual, case-by-case basis.

The following is a basic summary highlighting key aspects of the Master Settlement Agreement:

The settlement program applies to patients who are U.S. citizens and residents who had either an ABG II Modular Neck System or a Rejuvenate Modular Neck System implanted in their bodies in the United States, and who had a qualified surgery to remove and replace the recalled device on or before November 2, 2014.  The settlement program is also open to certain patients who have been deemed to be too sick or medically unstable to undergo a necessary revision surgery.

At Childers, Schlueter & Smith, our attorneys will immediately undertake to determine how the proposed settlement will affect each of our clients, and will work with each client individually to carefully consider the benefits of the proposed settlement so that they can make an informed personal decision on whether or not to participate.  As a nationally appointed leader in this litigation, founding partner Richard R. Schlueter will ensure each and every one of our clients has all of the information he/she needs to make the best choice for his/her unique situation.   Richard Schlueter has been involved in the various hip implant litigations (including DePuy ASR/Pinnacle, Zimmer Durom Cups, Biomet M2a Magnum and Wright Conserve Plus among many others) for several years, and has unique knowledge relating to hip implant failures and the injuries caused by those failures. Our current and future clients will be continue to be very well represented and informed during the entire process.

Attorneys representing those interested in participating in the Stryker hip implant settlement will have to register their clients in the program on or before the initial reporting deadline of December 14, 2014.  After that, the next deadline will be the formal enrollment of each individual patient who chooses to participate into the Settlement Program.  Those qualified claimants who would like to participate in the settlement program must enroll by March 2, 2015.  If less than 95% of the qualified claimants elect to participate in the settlement, Stryker has the ability to walk away and cancel the settlement program.  Stryker must make that decision on or before June 15, 2015.  Assuming the participation threshold is met and the settlement continues after June 15, 2015, the deadline to file claims for Enhanced benefits is September 30, 2015.  Additional compensation through the Enhanced benefits portion of the settlement will relate to damage to the femur, soft tissue damage, additional procedures and infection.  There is a cap on the Enhanced damages so that most total claims (Base award and Enhanced benefits) will be no more than $550,000.00 per claimant.

Patients-Suing-Over-Recalled-Stryker-Hip-ImplantBased on the timing of the deadlines in the proposed settlement, it is unlikely that any settlement payments will be made prior to late summer or early fall 2015.

For patients who are not eligible for the settlement program, Stryker’s existing program for reimbursement of eligible out of pocket costs, administered by Broadspire, remains available.  The decision to undergo a revision surgery is a medical decision, not a legal decision, and should be made only by patients in consultation with their surgeons.  If you were implanted with a recalled Stryker Rejuvenate or ABGII hip implant product but are not eligible for the settlement program, all of your legal rights and claims are preserved and you will not be affected so long as you have a filed legal claim with the Court.  Patients who have been implanted with a recalled Stryker hip in both hips (referred to as “bilateral” hip implants), in whom only one hip has been revised, will retain all of their claims and legal rights in regard to the unrevised hip, even if they participate in the settlement for their revised hip.

Childers, Schlueter & Smith is committed to continue litigating all claims for our clients who don’t qualify, who are arbitrarily penalized so as to not receive an offer under this proposal, who have not had revision surgery by today’s date, and those who choose not to participate in the proposed settlement.  If you have a recalled Stryker Rejuvenate or ABGII, please call us for a free consultation regarding your legal options.

For those looking for answers and guidance on these and/or any other Stryker hip implant related issues, we welcome you to contact our office for more information.

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FDA Regulates Approval of Drugs, Not How they are Prescribed

October 27th, 2014

People generally understand that the U.S. Food and Drug Administration regulates drug approval, but many would be surprised to learn that the FDA does not control how approved drugs are really prescribed.

Doctors are given great latitude to prescribe any drug for any reason that they deem medically appropriate, and are not required to tell the patient that the medication is being used for something other than the condition it was approved for. The process, commonly known as “off-label prescribing,” is legal and extremely common. Pharmaceutical companies are not permitted to market medications for off-label uses, however, and this practice has led to several large legal settlements.

What is “Off-Label?”

Off-label generally means that a medication is not being prescribed for a use specified in the FDA’s approved packaging label or insert included with the drug. The label is a written document that gives detailed information about approval uses and dosages, based on the results of clinical studies that the drug maker provided to the FDA to gain approval. According to WebMD, more than one-fifth of the outpatient prescriptions written in the U.S. are for off-label uses.

Doctors who choose to prescribe medications for a use other than what they were approved for have many significant responsibilities, including:

  • To be well informed about all medications they prescribe
  • Base their use on scientific rationale and sound medical evidence
  • Weigh the pros and cons of off-label prescribing
  • Consider the best interest interests of their patients at all times

There are some risks and benefits to off-label prescribing, and it is often helpful when patients have exhausted all other approved medication options. Cancer treatment often includes the use of off-label drugs for chemotherapy, since a drug approval for one specific type of cancer may also target many kinds of tumors. In these circumstances, off-label use of a drug represents the standard of care. Other common off-label uses of prescription medications include:

  • Beta-blockers that are FDA-approved to treat high blood pressure but are widely prescribed by cardiologists to treat heart failure
  • Tricyclic antidepressants used to control chronic pain
  • Antipsychotics prescribed for those suffering from attention deficit hyperactivity disorder (ADHD)
  • Selective serotonin reuptake inhibitors, FDA approved to treat depression, are also routinely prescribed for a wide variety of off-label uses, including borderline personality disorder, stuttering, alcoholism, and premature ejaculation

Because the FDA makes it clear that it does not regulate the practice of medicine, off-label drug use has become common, and occurs in virtually every medical specialty, particularly those in which the patient population is less likely to be included in clinical trials – pregnant women, children, or the elderly. Off-label prescription drug use can be a polarizing term because it is associated with both great benefit as well as great harm to patients, and health care professionals must continually education themselves about OLDU and its risks and benefits to patients.

We encourage all our patients to ask their doctor about the medication they are prescribing. Ask if the medication prescribed is FDA approved for the condition being treated. Ask why they think this medication would be better than another type or some other treatment. Ask what are the material risks of the medication and have they heard of any adverse side effects from it.

Asking these important questions will make you a more informed patient and hopefully keep you and your family safe from a prescription error or injury.

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DePuy Pinnacle Hip Implant Jury Trial Underway

September 4th, 2014

The first bellwether jury trial began yesterday over the controversial DePuy Pinnacle hip implant that has caused thousands of patients to needlessly suffer as a result of the product’s defective design and questionable marketing practices.

depuy-recallKathleen Herlihy-Paoli, claims the metal hips made by J&J, the world’s largest health-care company, leaked cobalt and chromium material into her bloodstream, causing an infection and other complications that ultimately required the devices to be surgically removed.

This marks the first jury trial over the DePuy Pinnacle Hip Implant device that was first brought to market by Johnson & Johnson and its subsidiary DePuy Orthopaedics in 2005. With more than 6,000 cases now pending in the Pinnacle MDL consolidated before the Honorable U.S. District Judge Ed Kinkeade, allegations of inadequate testing, failure to warn and defective design of the hip implant device will all be discussed and debated. The Pinnacle jury trial is expected to last 6-8 weeks.

J&J’s DePuy unit ignored signs the Pinnacle hips suffered from design flaws and assured doctors the metal devices worked “99.9 percent of the time,” Mark Lanier, a lawyer for a Montana woman who sued after complications forced her to have the device removed, told jurors today in Dallas federal court on the first day of trial of her lawsuit.

Although not recalled like the DePuy ASR hip implants, Bloomberg.com reports that:

J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval.

J&J touted the metal-on-metal implants, first sold in the U.S. in 2005, as a design that would last 20 years and offer greater range of motion.

pinnaclePatents all over the world, and doctors alike, now know these claims are simply inaccurate and completely misleading. It is yet another prime example of Big Pharma putting profits over people.

The case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 12-cv-3590, U.S. District Court, Northern District of Texas (Dallas).

As more develops in this trial it will be updated here.

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Childers, Schlueter & Smith Files 25 More Stryker Hip Lawsuits

September 4th, 2014

Atlanta, Georgia based law firm Childers, Schlueter & Smith, LLC recently filed another 25 Stryker hip replacement lawsuits, joining nearly 1,800 other Stryker lawsuits pending in U.S. District Court. Stryker lawsuits have been consolidated into multicounty litigation (MCL) in the Superior Court in Bergen County, New Jersey, and into multidistrict litigation (MDL) in the U. S. District Court of Minnesota. The MDL is being overseen by U.S. District Judge Donovan W. Frank, and is expected to grow by hundreds of new hip implant recall cases in the next few months alone.

Many of the new plaintiffs in the MDL proceedings have undergone surgery to have their hip stems removed, but some are still in the medical monitoring phase to determine if a hip implant revision surgery will be necessary in the future. These lawsuits, like the others, claim that Stryker did not adequately test the artificial hip stems to ascertain that they would not fret, corrode, or otherwise deteriorate and lead to severe metal toxicity in those receiving the implants. The lawsuits also allege that:

  • Stryker’s representation that the hips stems would not fret or corrode were misleading to both physicians and consumers
  • Stryker marketed the device as a perfect fit for younger patients, leading doctors and patients to believe that it was superior to other hip implants available
  • The hip stems contain design and manufacturing defects that can cause serious or even permanent damage to patients
  • Stryker aggressively marketed the hip implants without informing consumers about the risks when safer alternatives were available

Stryker Recall

The Rejuvenate and ABG II hip stems were voluntarily recalled by Stryker in June 2012 after reports of corrosion and fretting at the modular neck-junction were received. At the time of the recall, Stryker issued a report stating that the neck components of Rejuvenate and ABG II are made of chromium and cobalt, the stems are coated with titanium, and the two parts wearing against each other will generate metallic debris released into the patient’s bloodstream or surrounding body tissue.

The metallic debris can cause patients to experience negative side effects, including local tissue reactions, swelling, anddepuy-recall pain. It can also require the removal of the lower portion of the modular stem due to design failures in the human body. Stryker advised that hip implant recipients should have their blood tested for metal ions and imaging screening, even if they are not experiencing any problems with their hips.

CSS is experienced in handling the legal matters faced by claimants that have recalled Stryker hip device(s) and ensures its clients are well informed on the monitoring process of their claims. In addition to these services, the challenges of reimbursement for past and future medical expenses, mileage and lost wages through the Broadspire process are handled for free to CSS clients while the Firm pursues the product liability claim on a contingent fee basis. (no fee until your claim is settled or tried to verdict in favor of a client).

For more information of the Top 10 Things All Stryker Hip Implant Patients Need To Know check out our previous blog on the hip implant recall.

news_CBS_SchlueterChilders Schlueter & Smith, LLC is taking a leading role in the National litigation by appointment of its partner, Richard Schlueter, by Federal Judge Donovan Frank to the Plaintiff Steering Committee ( PSC)  in MDL  13-2441 IN Re: Stryker Rejuvenate and ABG II hip implants products liability litigation.

If you have questions about your potential Stryker hip implant recall case and want answers, please contact us today. Our hip implant lawyers are standing by to help and will discuss your claim with you in detail. All inquiries are kept completely confidential.

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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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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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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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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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Xarelto: More Dangerous than Warfarin?

August 11th, 2014

Cases have recently been filed in courts around the U.S. relating to bleeding injuries and death caused by the drug Xarelto.

Xarelto-pill_MainXarelto is an oral anticoagulant manufactured by Bayer Pharmaceuticals and Janssen Pharmaceuticals (a Johnson & Johnson affiliate).  It was brought to market in 2011 and has been extensively promoted as an alternative to warfarin (coumadin).  Xarelto was originally approved to prevent blood clots (and stroke) in patients with atrial fibrillation and in patients undergoing knee or hip replacement surgery.

Until the release of Xarelto and other new oral anticoagulants (“NOACs”), warfarin had long been the standard care for preventing blood clots.  The NOACs, including Xarelto and Pradaxa, have been widely marketed by their manufacturers as better alternatives to warfarin because patients would no longer have to undergo regular blood testing and frequent doctor visits to monitor proper dosage and kidney function.

It has since been demonstrated, however, that the claim of added convenience of Xarelto comes at a steep and often devastating cost to many patients.  Xarelto has been linked to medical complications including intestinal bleeding, rectal bleeding, blood clots, brain hemorrhaging, pulmonary embolism, and deep vein thrombosis.  Many of these conditions can lead to severe disability or death.  Ironically, it appears that these devastating bleeds could often be prevented if the patients on the NOACs underwent regular blood testing – just like patients taking warfarin – to ensure that their dose was appropriate.  Such a recommendation, however, would be in stark contrast to the marketing strategy for Xarelto – that it is more convenient and thus superior to warfarin.  As a result, no such recommendation has been made by the manufacturers of Xarelto.

xarelto 2The failure of manufacturers to recommend blood monitoring in patients taking Xarelto is even more dangerous in light of the fact that, unlike warfarin, there is no known antidote to stop bleeding caused by this medication. If you develop a bleed from taking warfarin, simple vitamin K therapy is generally sufficient to treat the condition and promote clotting.  This is not the case with Xarelto.  Until an effective antidote is created and approved for use in Xarelto patients, there will continue to be an unreasonably high number of uncontrollable bleeds and deaths caused by the drug.

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