Articles Posted in Drug and Medical Device Litigation

The new hepatitis C drug was hailed as “miraculous.” Physicians on a panel of experts granting U.S. Food & Drug Administration approval enthused it was “a game changer,” able to cure a stubborn, painful disease in just three months. What the experts did not know was that the FDA’s own drug quality inspectors had recently strongly advised against giving the drug a stamp of approval. West Palm Beach drug litigation attorney

In a 15-page disciplinary report, FDA inspectors eviscerated the drug manufacturer’s primary testing laboratory for numerous failed quality control measures, including:

  • Improperly-stored samples;
  • Inadequately-reviewed failures;
  • Testing results vulnerable to tampering.

Our West Palm Beach drug litigation lawyers know that poor quality control for prescription drugs has been a noted problem where overseas-manufactured generic brands are concerned. However, what this instance highlighted was the fact that brand name prescription medications made by well-known, highly-profitable corporations in the U.S. are also plagued by these same concerns – and oversight appears to be lax.

Despite the fact that the FDA’s own inspectors sounded the alarm internally about the hepatitis drug, those issues were resolved confidentially – without any further inspection required before the medications were approved for marketing and sale to the American public.

This does not appear to be an isolated example, according to an ongoing investigation by Kaiser Health News. In fact, some drug companies pay expensive fees for expedient FDA reviews.
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For nearly 20 years, reports of widespread failures of more than 100 medical devices leading to scores of serious personal injuries were concealed from the public in a federal database about which few patients, doctors or regulators knew. medical device litigation

Earlier this year, a Kaiser Health News investigation revealed more than 5.7 million medical device-related injuries among patients across the U.S. Reports of those were filed through an internal FDA “alternative summary reporting” archive, rather than the more heavily-scrutinized public database known as MAUD. That database is used by physicians, public health advocates, medical device engineers and our own South Florida medical device litigation attorneys to identify patterns of problems with medical devices that put patients at risk. KHN reported that not even the FDA’s own commissioner was aware of the database, which included a voluminous list of devices like breathing machines, surgical staples, implantable defibrillators, breast implants, tooth implants and and in-heart balloon pumps.

And that wasn’t even the only “secret” database. The FDA also had a “registry exemption” that device manufactures could request to use for reporting injuries resulting from more controversial medical devices, such as pelvic mesh. Another allowed for “litigation complaint summary reporting,” where medical device manufacturers could send a single injury report that might detail thousands of pending lawsuits predicated on similar patient injuries. Continue reading

The Da Vinci Surgical Robot, manufactured by Intuitive Surgical, Inc., is used in several medical specialties including: Urology, Gynecology, Cardiothoracic, Colorectal, Head & Neck, and General Surgery. Specifically, the Da Vinci Surgical Robot has been used for hysterectomies, prostate removal surgeries, gastric bypasses, gall bladder removals, and thyroid cancer surgeries. Unfortunately, numerous Da Vinci Surgical Robot procedures have led to lawsuits claiming patients have suffered serious life threatening injuries, and in some cases death. Said injuries include, but are not limited to, the following: peritonitis, sepsis, bleeding, perforated/punctured blood vessels, organs or arteries, burned/torn intestines, bowel injuries, bladder and ureteral injuries, and vascular injuries.
The Da Vinci Surgical Robot was designed as a minimally invasive way for surgeons to perform certain surgeries. One of the primary benefits was its ability to provide surgeons a greater range of motion with the use of a joystick-like control. However, compared to surgery performed by hand, many physicians are uncertain as to the benefits of the procedure. Specifically, the Da Vinci Surgical Robot has many significant disadvantages. Primarily, the sensory feedback upon which surgeons rely is gone. The Robot cannot discern whether body parts are firm, bony, soft, or hard. Without this information, the wrong body part may be accidentally cut. Studies have indicated that on average the robotic surgery takes longer and subject patients are more likely to have post-surgical complications. Moreover, as a result of the Da Vinci’s modernistic approach, many physicians lack the required training, and are permitted to use the machine unsupervised after only a few training sessions.
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Fungal Meningitis is an infection of the protective membranes of the brain and spinal cord. Over the last few months, a deadly fungal meningitis outbreak has swept across the United States. Recently, both CDC and FDA investigations have established that the outbreak is directly related to contaminated epidural steroid injections produced by the New England Compounding Center (NECC), in Framingham, Massachusetts. The specific drug manufactured by NECC is a steroid called methylprednisolone. Currently, over 200 people across 16 states, including Florida, have been diagnosed with fungal meningitis linked to the contaminated injections. As of November there have been 23 reported deaths.

The symptoms of fungal meningitis include, but are not limited to the following: fever; headache; stiffness of the neck; nausea and vomiting; photophobia (sensitivity to light); new onset of weakness or numbness in any part of the body; slurred speech; increased pain; redness; swelling at the injection site; and/or altered mental status. According to the CDC, the onset of symptoms in most patients has occurred from one to four weeks after receiving the infected epidural injection. However, please note longer and even shorter periods have been reported.
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untitled.bmpOur Miami-Dade Drug litigation lawyers have been following the developments with regard to Pradaxa. Pradaxa was released in October 2010 with great fanfare. It is an anti-coagulant drug, or “blood thinner.” Pradaxa is typically prescribed by your doctor for the treatment of a heart condition known as atrial fibrillation, or “afib,” that is not caused by a heart valve problem.

Atrial fibrillation, or “afib,” is an irregular heartbeat. It is one of the most common irregularities involving the atria of the heart. With “afib,” blood does not flow properly from the atria to the ventricle of the heart. Since the blood does not flow properly, there is an increased risk for the development of blood clots, and consequently stroke.

To treat “afib,” your doctor may have prescribed Pradaxa for you. Pradaxa was, and is, touted as being a major advancement over other anti-coagulants, such as Coumadin, as it requires less monitoring of blood levels. Unfortunately, however, it appears to have come with a different set of problems.

Pradaxa has been linked to an increased risk of life-threatening bleeding. During the first (3) months it was on the market, the FDA received more complaints about it than 98.7% of other drugs. Further, during the first year it was on the market it has been linked to more than 360 deaths due to internal bleeding. As a result, on December 7, 2011 the FDA announced it was launching a safety review of Pradaxa, only (14) months after it came on the market!

One of the little known facts about Pradaxa is that, unlike with other anti-coagulants such as Coumadin, there is no way to reverse its affect. In other words, there is no known drug or agent that can be administered to reverse the anti-coagulant effects of Pradaxa should bleeding occur, such as can be done with Coumadin.

Despite the FDA’s investigation of Pradaxa, there are several hurdles to proceeding with a suit against its manufacturer. Among them, Florida has adopted the “learned intermediary doctrine.” This means that the manufacturer’s duty to warn of risks associated with a drug is directed to the doctor, not the patient. Nevertheless, the courts do recognize a cause of action brought by a patient on the basis that the manufacturer misrepresented information to the doctor, and the doctor relied upon the misrepresentation in prescribing the drug, such as Pradaxa, to the patient. See the court’s decision in Mardegan, 2011 U.S. Dist. LEXIS 89787.
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Our South Florida medical device litigation attorneys have been following the DePuy hip case implant developments closely. In August of 2010, DePuy Orthopaedics, Inc., a division of Johnson & Johnson, recalled its ASR XL Acetabular metal-on-metal hip implants. However, as early as 2009, the Food and Drug Administration notified DePuy that it was denying the company’s application to sell the implants domestically. Consequently, according to the New York Times article, “Hip Device Phaseout Followed F.D.A. Data Request,” it appears Johnson & Johnson executives initiated a product phaseout of DePuy ASR hip implants as early as 2009, in lieu of a complete recall, only weeks after the Food and Drug Administration requested supplemental safety data from the company.

In 2009, reports from countries outside the United States, illustrated the device was performing less productively and safely than data submitted by DePuy itself. On average, hip implants should last fifteen (15) or more years. Recently, research has surfaced indicating that DePuy’s hip implant failed up to 49% of time in the United Kingdom, and globally failed in patients within a few years of hip replacement. However, citing slow product sales, rather than factors related to safety, DePuy planned to phase out the hip implant globally by 2010.

Several design defects in the ASR hip implant can cause product failures, resulting in DePuy hip implants recall cases. Patients may suffer from “metallosis”, or metal poisoning. Metallosis is a condition associated with metal-on-metal implants. When metal-on-metal hip implants are used the two sides of the implant can rub together, and, in doing so, shed tiny metal particles shown to cause inflammation, soft tissue damage, and/or necrosis. Specifically, the ASR hip implant has cobalt and chromium elements which the Food and Drug Administration not only considers hazardous, but potentially carcinogenic. Other known problems include loose-fitting implants, friction transfer to the acetabulum, and hip implant dislocations. Moreover, design defects like the cobalt/chromium metal construction, shall cup depth, and exceptionally low angle tolerances can cause malfunctions leading to costly supplemental surgeries, known as “revision surgeries”, and/or additional hip replacements.

Presently, it is not known how many patients received ASR XL Acetabular metal-on-metal hip implant. However, according to the aforementioned New York Time’s article, in an eight year period, roughly 93,000 patients received the defective implant, one-third domestically. In Florida, cases are currently being filed that share factual issues surrounding whether DePuy is strictly liable for defectively designing and/or manufacturing the ASR XL Acetabular Hip System, and whether DePuy failed to provide adequate warnings concerning the device to consumers. See Barnes v. Bayside Orthopaedics, Inc., 2012 WL 162368 (M.D.Fla.). Ultimately, patients may suffer irreversible damage, and the longer patients wait to have the ASR revised, the more permanent and damaging the effects can become.

Strict liability in Florida extends to those in the distributive chain including manufacturers and other entities responsible for the sale of a prosthetic device. See Porter v. Rosenberg, 650 So.2d 79, 81 (Fla. 1995). Consequently, it is imperative to note that retailers, like manufacturers, can be held liable for injuries resulting from defective products. However, physicians are generally not subject to strict liability. Courts tend to treat healthcare providers akin to users as opposed to distributors. Moreover, in many product liability cases, including DePuy hip implants, choice of law rules may be a factor that needs to be considered. Under Florida law, a true conflict exists when two or more states have legitimate interests in a particular set of facts in litigation and laws of those states differ or would produce different outcomes. See Chapman v. DePuy Orthopedics, Inc., 760 Supp.2d 1310 (M.D.Fla. 2011). Choice of laws rules carry great significance, nor more than determining which state’s statute of limitations to apply. In Florida, the state has a four-year statute of limitations for product liability claims.
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A Palm Beach County woman is suing Medtronic Inc. for products liability. English says she developed uncontrolled bone growth in her spine after she received an Infuse Bone Graft implant during spine surgery.

The Infuse Bone Graft, which is bioengineered, is not FDA-approved for posterior-approach lumbar spine surgery. In her Florida defective medical device complaint, English claims that Medtronic misrepresented the risks involved with getting an Infuse implant and improperly marketed the device for uses not approved by the FDA.

English says that the extra bone growth she experienced has caused her to experience nerve compression, which has resulted in ongoing, chronic, and serious pain. Her products liability lawyer says that research had shown that use of Infuse in off-label surgeries can lead to this type of bone growth around and into the spine.

In South Florida, state regulators have discovered a sobering trend: at least 41 South Florida doctors treat both drug addicts and pain patients. Experts worry that this combination of medical specialties could be dangerous, because it puts potentially addictive drugs to treat pain alongside a population that may already have drug dependencies.

According to an article in the Miami Herald, many of the doctors dispensing painkillers at South Florida pain clinics do not have special certification in addiction or pain management.

New Jersey requires doctors to be board certified in pain management before they can prescribe painkillers, but Florida doctors are allowed to dispense painkillers provided they have completed an eight-hour training course, have a valid medical license, and have approval from the Drug Enforcement Administration (DEA).

Many of these doctors have reportedly been disciplined for recklessly prescribing addictive drugs, but they can continue prescribing the drugs after they return from suspension.

Source: South Florida pain-clinic doctors also treat drug addicts, Miami Herald, December 29, 2009 Continue reading

While methadone is prescribed by doctors, nurse practitioners, and osteopaths as a painkiller to treat conditions resulting in severe pain, the drug is implicated in two times as many painkiller-related fatalities as the drugs Vicodin and OxyContin. According to Dr. Howard Heit, a pain medication specialist, many patients that take the drug as prescribed can suffer adverse side effects, including death.

Federal regulators admit that it took them awhile to recognize physician ignorance related to the drug and the dangers that could arise when doctors prescribe methadone as a painkiller. The government cites “imperfect” systems as a cause for the oversight. As late as 2006, the Food and Drug Administration-approved package insert was still recommending a dangerously high dosage.

The number of deaths citing methadone as a contributing cause between 1999 and 2005 was 4,462, which federal officials say may be an underestimation. In 2007, the state of Florida alone reported 785 deaths caused by methadone. Between 1998 and 2006, the number of methadone prescriptions grew by 700%, says the DEA.

One main problem is that many doctors don’t fully comprehend the way methadone metabolizes and how patients can have different responses.

Causes for error include:

• Prescribing too much methadone too quickly.
• Failing to warn patients that it is dangerous to mix methadone with sedatives or alcohol.
• Failing to follow up during the first week a patient is taking the drug.

The FDA is considering mandating that doctors take classes that focus on prescribing narcotics.

Federal regulators and drug manufacturers are supposed to make sure that any medications that are recommended, manufactured, and placed out in the market are safe for use. Allowing a dangerous drug into the marketplace or failing to warn of a drug’s potential side effects can be grounds for a drug litigation lawsuit if someone gets sick or dies as a result. A doctor may be subject to a medical malpractice lawsuit if he or she prescribes a drug to a patient but fails to warn of dangers or doesn’t prescribe the correct dosage.

Methadone is successful as painkiller, but can be deadly,, August 17, 2008
Painkiller more available for abuse, USA Today, July 13, 2008

Related Web Resources:

Methadone, NIH Continue reading

According to British researchers, the use of Topiramate, an anti-epilepsy drug, increases the chances of pregnant women giving birth to babies with birth defects by up to 14-fold-especially when the drug is taken along with the drug Valproate. The study involved 203 women that became pregnant while taking Topiramate (Topamax is the brand name sold by Johnson & Johnson) alone or with other epilepsy medication.

Findings from the study included:

• 18 spontaneous abortions
• 5 induced abortions
• 2 stillbirths
• 178 births
• 16 infants were born with major birth defects
• 4 infants were born with cleft lips or palates
• 4 babies had genital birth defects

However, because the study involved only 203 women, experts have said that there is still statistical uncertainty related to this new data.

Topiramate has caused similar birth defects in animals. The fact that studies of other epilepsy drugs have revealed an increase in birth defect risks indicates that all of these drugs may affect the reproductive process.

Of the approximately 2.7 million Americans with epilepsy, Topamax makes up 1 out of every 5 prescriptions. Doctors say that even though there are risks involved with taking anti-epilepsy drugs, preventing epileptic seizures that would otherwise harm unborn babies-perhaps even more severely than the side effects that use of the drug can cause-is essential.

If you or someone you love was injured because of a dangerous pharmaceutical drug, you may be entitled to personal injury or wrongful death compensation. Drug manufacturers are supposed to test their medications before making them available to users and warn of any adverse side effects.

Our South Florida drug litigation law firm can determine whether you have grounds for a claim. If a drug maker or seller knowingly concealed risks, failed to conduct the proper and full product tests, or neglect to warn doctors and consumers of potential dangers, we know how to investigate any of these factors and prove your case.

Epilepsy drug Topamax linked to birth defects, Los Angeles Times, July 22, 2008

Study links epilepsy drug to increased birth-defect risk, USA Today, July 21, 2008

Related Web Resources:

Epilepsy and Pregnant Women, Continue reading

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