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$247 Million Verdict in DePuy Pinnacle Hip Trial

A Texas jury has returned a $247 million verdict for six plaintiffs who claimed they were injured by DePuy’s Pinnacle hip implants.
It’s the third major verdict against the company in four trials over the metal-on-metal replacement hips.
“The companies should have done the right thing when these serious medical concerns became known many years ago.” The verdict includes $78 million in compensation for the plaintiffs’ injuries and more than $168 million in punitive damages — awards a jury can grant to punish a defendant, in this case the hip manufacturer, if their behavior is found to be especially harmful.
Verdict Brings Pinnacle Verdicts to $1.7 Billion So Far The Texas case was the fourth bellwether trial in a massive multidistrict litigation (MDL) over defective Pinnacle hips.
Bellwether cases are drawn from the various lawsuits and used as “test cases” to determine the legal merits each side has in future trials.
In January 2016, five plaintiffs won a $502 million verdict against DePuy in the second bellwether trial.
The court later slashed the amount to $510 million.
Problems With Metal-on-Metal Hips Like the DePuy Pinnacle Implant The DePuy Pinnacle replacement hip was part of a generation of metal-on-metal hip implants.
Metal-on-metal hips mean both parts of the ball-and-socket joint are made from metal.
Johnson & Johnson agreed to resolve more than 9,800 lawsuits over DePuy’s ASR hip implants for $4.4 billion in 2013 and through a settlement extension in 2015.

Xarelto Bleeding Trial Opens in Philadelphia

The trial will hear a case filed by Lynn Hartman and her spouse, alleging that Xarelto’s side effects cause Ms. Hartman to experience severe internal bleeding.
The claim is a product liability suit against the manufacturer.
Judge to review testimony re: sales rep contact The opening of the case was delayed half a day as the judge weighed concerns that a sales representation for Janssen had contacted Ms. Hartman’s physician improperly.
Janssen attorneys indicate that the sales rep called the office, but did not speak with the physician in person.
The trial judge is reviewing the testimony.
Internal bleeding caused by Xarelto Xarelto has been available since 2011.
In addition, while an antidote to uncontrolled bleeding with warfarin is widely known and available, no antidote exists for bleeding with Xarelto and the other second-generation drugs.
Ms. Evans’s case is the first to go before a judge.
Additional “Xarelto Bleeding Trial” Resources: 1.
November 6, 2017.

Weekly Roundup 11.17.15

Our days are darker earlier and soon we shall slow down to a crawl.
And in fact, Eye on FDA will be on hiatus until after the Thanksgiving holiday.
Big Day for Regenerative Therapy – Since in office Scott Gottlieb has announced multiple initiatives aimed at enhancing the development of new therapies – in the past few months in devices – and this week with the issuance of multiple guidance documents – in regenerative therapies.
The framework brings clarification on a comprehensive scale.
First Device for Opioid Withdrawal – FDA announced approval of the first device intended to ease opioid withdrawal symptoms.
Information from the manufacturer can be found here.
The approval happens in a week when there was also publication of a head to head study of two medicines approved for opioid addiction treatment.
Two Warnings from FDA – The agency issued two unrelated public safety communications this week.
The agency noted that in some cases industrial grade silicon was being used and said any silicone injections for this purpose, often by unlicensed practitioners, were an unapproved use and could result in serious adverse events.
Upcoming Events to Keep an Eye On Next week being Thanksgiving Week, there are no FDA scheduled events and you can bet Members of Congress are not sticking around.

DePuy Metal Hip Settlement on Table for Revisions After March 2015

Johnson and Johnson Inc. has been in the legal “hot seat” for some time regarding two of its metal-on-metal hip prosthetic units—the ASR XL acetabular system and the Pinnacle acetabular system.
To prevent the first of the ASR hip implant claims from going to trial, the pharmaceutical giant offered the initial $600,000 DePuy metal hip settlement in August 2012.
The first DePuy metal hip settlement was for three litigants who had been implanted with DePuy ASR implants but, due to damaging side effects, were forced to undergo early revision surgery.
The problems leading to such a radical action were all similar in nature.
The DePuy metal hip settlement provided compensation for the pain and suffering that metal-on-metal hip prosthetic recipients experienced routinely.
In many cases, the pain experienced was attributed to the build-up of metal debris in the artificial joint and surrounding tissues, a condition known as metallosis.
This metal debris came from the cobalt and chromium of the prosthetic itself.
It frequently led to pseudotumors around the joint, tissue death, and even some bone loss leading to fracture or dislocation.
The continuing DePuy metal hip settlement program was then offered in phases for recipients that had undergone early revision surgery.
Taking advantage of the latest extension is very good news for patients who have suffered with the DePuy ASR implant and had to undergo revision surgery within this time window.

Blood Thinner Medication Lawsuit Alleges Xarelto Caused Dangerous Bleeding

A blood thinner medication lawsuit has been filed against the makers of Xarelto.
Plaintiff Kathy S. says she took the prescription blood thinner from around Nov. 18, 2015 through Dec. 20, 2015.
When taking Coumadin, the patient has to have INR (international normalized ration) blood tests to determine how fast the blood clots.
The blood thinner medication lawsuit alleges the studies that led to Xarelto’s approval were flawed and conducted negligently.
The blood thinner medication lawsuit alleges that because the warfarin group was so poorly managed, Xarelto appeared to be equal or better than warfarin.
The blood thinner medication lawsuit says that doctors have “to be able to balance the dose that the blood is thinned enough to reduce the risk of stroke, but not thinned so much as to increase the risk for a major bleeding event.” The drug’s makers are accused of knowing the risk and the need for blood monitoring, but failing to notify patients, doctors and the FDA.
“Importantly, Xarelto’s significant risk of severe, and sometimes fatal, internal bleeding has no antidote to reverse its effects, unlike warfarin,” says the blood thinner medication lawsuit.
From June 2011 to June 2012, the FDA recorded 1,080 Xarelto “Serious Adverse Event” reports.
The Blood Thinner Medication Lawsuit is Case No.
2:17-cv-11686-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.

Class II FDA Recall Issued Over Attune Knee Tibial Loosening

Numerous patients have been complaining of Attune knee tibial loosening, with many of them having to undergo revision surgery to resolve knee implant complications.
According to the recall, a small wire spring coil was reportedly loosening and detaching soon after the device was implanted.
With reports of Attune knee tibial loosening, DePuy joined a group of knee implant manufacturers that have had to issue their own product recalls.
Furthermore, 38% of the recalled knee implants were manufactured by DePuy Orthopaedics.
DePuy Orthopaedics released a newer model of the Attune knee implant, the Synthes Attune Knee System, after reportedly spending six years developing the product.
It is important to note that DePuy Orthopaedics had specifically developed the Synthes Attune Knee System as a superior option for patients seeking knee implants.
Lastly, the Gilderight Articulation feature helps protect the body’s soft tissue and keeps the leg’s patella in place when the knee is bent.
Even though this device is supposed to be longer lasting and superior than other knee implants on the market, reports of Attune knee tibial loosening were submitted.
It is important to note that most patients who receive knee implants are not expected to undergo revision surgery for 20 years, making the reports of early device failure very concerning.
In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions.

Stryker Metal Hip Complications Alleged in Product Liability Lawsuit

Stryker Corporation is facing a new product liability lawsuit alleging serious Stryker metal hip complications, which eventually forced the claimant to undergo revision surgery.
The Stryker metal hip lawsuit was filed by a Tennessee man, alleging the implant’s defective nature caused him to develop Stryker metal hip complications.
When Samuel opted for the Stryker metal hip implant, Samuel and his physician relied on the marketing materials provided by Stryker Corporation and received no information regarding Stryker metal hip complications from the company.
The Stryker metal on metal hip implant was supposed to restore movement to his damaged hip bones and was marketed as a superior choice in the orthopedic market.
According to the lawsuit, over time, Samuel’s Stryker metal hip complications worsened, and on June 15, 2016, Samuel underwent revision surgery.
During the revision surgery, it was discovered that an infection had developed around the hip implant site.
Metal hip implants became especially popular among younger patients, hoping to live an active lifestyle after hip implant surgery.
However, numerous patients have reportedly developed metal hip implant complications, stemming from the metal components.
When the ball and socket components of device interact, metal ions are shed into the bloodstream and can lead to blood metal poisoning.
2:17-cv-02792-SHL-cgc, in the U.S. District Court for the Western District of Tennessee, Memphis Division.

Infection Following Open Heart Surgery Requires Years of Therapy

He had undergone open heart cardiac surgery at the VA Ann Arbor Healthcare System in February 2017.
Durging that surgery, Bernard says, he was “exposed to a rare and potentially fatal bacteria via Sorin 3T Heater-Cooler Systems used to regulate body temperature.” Bernard claims that the bacteria he was exposed to was mycobacterium avium complex (MAC) which is a “slow growing subset” of the nontuberculous mycobacterium (NTM) class.
The heart surgery infection lawsuit further maintains that MAC puts patients at risk for infection after heart surgery.
The bacteria, although it occurs naturally in the environment and rarely causes illness, will actually slowly grow within a patient once a patient becomes exposed to it.
It can purportedly take anywhere between several months to six years before symptoms of an infection appear.
Some of the symptoms of an M. Chimaera infection following open heart surgery may include any of the following: pain, night sweats, fever, unexplained weight loss and fatigue, and muscle and joint pain.
3T Heater-Cooler System Facts The Sorin 3T Heater-Cooler System functions to regulate body temperature while a patient undergoes surgeries such as open heart surgery.
If not properly sanitized and cleaned, an NTM culture can develop.
The Centers for Disease Control and Prevention issued an Interim Practical Guidance communication to healthcare departments and medical providers warning them of the risks involved in patients contracting an NTM infection.
8:17-cv-02568-RAL-MAP, in the U.S. District Court for the Middle District of Florida, Tampa Division.

Woman Suffers Permanent Hair Loss After Taxotere

A plaintiff, Judy W., has filed a products liability lawsuit against the manufacturers of Taxotere, Sanofi S.A. and Aventis Pharma S.A., alleging permanent hair loss due to taking Taxotere for chemotherapy treatment.
According to the permanent hair loss after Taxotere lawsuit, Judy is a resident of the state of Louisiana.
Judy’s claim is filed as part of a large multidistrict litigation, or MDL, centered on allegations that the use of Taxotere as a chemotherapy drug causes permanent hair loss after Taxotere use, which is also known as alopecia.
Women like Judy are filing permanent hair loss after Taxotere lawsuits alleging that the drug, used as treatment for chemotherapy causes them to suffer from permanent alopecia, or hair loss, and allege that they were never warned about these adverse side effects and complications before the drug’s use.
The difference with Taxotere is that women who undergo chemotherapy treatment with other drugs are aware and expect that they might suffer from hair loss.
Their hair should be able to grow back once chemotherapy treatment is done.
In the permanent hair loss after Taxotere lawsuits, women allege that they were never warned that permanent alopecia may result.
The permanent hair loss after Taxotere lawsuit further alleges and maintains that Sanofi had warned of potential adverse side effects and complications in Europe and Canada, but never alerted the U.S. patients of such warnings.
Additionally, the lawsuit rests the obligation and responsibility for producing and selling a product that is not unsafe and dangerous for patient use on the shoulders of the manufacturers and blames them for allowing patients and victims of this medication to suffer from permanent hair loss due to these alleged omissions and acts.
The Taxotere Lawsuit MDL is In re: Taxotere (Docetaxel) Products Liability Litigation, MDL No 2740, in the U.S. District Court for the Eastern District of Louisiana.

Anticonvulsant Dilantin Linked with Cerebellar Ataxia Side Effects

The popular anticonvulsant medication Dilantin has been linked with serious side effects, including a condition known as cerebellar ataxia.
The severity of the seizures varies from person to person, but the basis is the same: during a seizure, the rate at which the brain normally fires neurons suddenly increases to a very rapid pace, which can then cause movement that the patient themselves can’t control.
But it has actually been linked with some pretty severe side effects, including cerebellar ataxia.
Essentially, cerebellar atrophy occurs when a patient’s brain tissue degenerates over time, which can have a number of severe and even permanent effects, such as cerebellar ataxia.
A study published in the Seizure European Journal of Epilepsy looked at the connection between Dilantin and cerebellar ataxia.
The study found that the length of time a patient uses Dilantin will drastically affect how likely they are to develop extreme side effects like cerebellar ataxia.
So a long-term Dilantin patient is more likely to develop cerebellar ataxia than a patient who has only used Dilantin for a short time.
For some patients, the treatment for cerebellar atrophy is simply to stop taking Dilantin.
If you have taken the anticonvulsant Dilantin and have since begun to suffer from cerebellar ataxia or other serious symptoms, you may be able to file a lawsuit against the drug’s manufacturer, Pfizer.
In general, phenytoin lawsuits are filed individually by each plaintiff and are not class actions.