Monthly Archives: April 2013

Generic Drug Side Effects Lawsuit News

Two years ago the Supreme Court unknowingly created a two-tiered system for the liability faced by drug makers. In Pliva v. Mensing, the court severely limited the conditions under which consumers of generic drugs could sue the manufacturers.
The court ruled that since makers of generic drugs did not have control over the content of warning labels, they could not be held liable for failing to alert patients to the risks of taking their drugs.
Now, the Supreme Court is set to decide a number of cases that challenge that earlier ruling.
At issue is a group of three consolidated cases brought by women who took the generic equivalent of Reglan for stomach ailments and developed a serious neurological disorder. Appeals courts ruled against the drug makers, saying that the federal regulatory regime did not block claims under state law.
If the makers of generics can’t be held liable, who can? The position of the generics is one in which they would be immune from liability for selling a product with inadequate warnings — even though the name-brand company selling the same drug with the same warnings would be liable.
That position would leave the women who were harmed by the generic version of Reglan with no recourse.
In another similar case heard by the court recently, Bartlett v. Mutual Pharmaceutical Company, defendant Karen Bartlett developed a rare but severe reaction to the anti-inflammatory drug Sulindac after a doctor prescribed it to treat shoulder pain in 2004.
Sulindac, similar to Ibuprofen, is in a class of drugs known as nonsteroidal anti-inflammatory drugs — or Nsaids — which are in widespread use and was approved by the FDA in 1978. Within weeks of taking the generic version of Sulindac, Bartlett developed toxic epidermal necrolysis, a severe form of a related condition called Stevens-Johnson Syndrome. The reaction permanently damaged her lungs and esophagus and rendered her legally blind.
Bartlett sued Mutual Pharmaceutical Company, which made the generic drug she took, arguing that the drug’s design was dangerous and defective. A jury in the Federal District Court in Concord, N.H., awarded her $21 million. An appeals court upheld the verdict.
Now Mutual Pharmaceutical Company has appealed the case to the U.S. Supreme Court, maintaining it can’t be held liable since it had no control over the drug’s warning label or design.
If the court agrees with Mutual and rules that generic companies cannot be sued for defective products, what recourse will patients have who were injured by a generic drug? Then the question becomes can a generic manufacturer be held liable for anything?
It is worth noting that currently 70 percent of prescriptions in the U.S. are being filled with generic drugs and of that number, a third of generics have no brand-name competitors.
If the Supreme Court rules in favor of the makers of generic drug in these cases, who will remain liable if the drugs harm patients?
Karen Bartlett is desperate to know the answer to that question.

DePuy Hip Replacement Implant Lawsuit News

Hip Implant LawyersA jury in Chicago rejected claims this week that the DePuy orthopedics unit of Johnson & Johnson inappropriately marketed an artificial hip, which the company recalled in 2010.
This comes in direct contrast to the $8.3 million dollar verdict awarded last month against DePuy in Los Angeles District Court which found that the company had knowingly marketed a faulty hip implant that it later recalled.
This verdict came in the second trial of over 10,000 pending lawsuits involving the all-metal device, which was known as the Articular Surface Replacement or A.S.R. This was part of a once-popular class of metal-on-metal hip implants developed almost a decade ago. It was an attempt to improve on traditional joints that were made of metal and plastic. But shortly after the release of the A.S.R., complaints started coming from patients and doctors about implant failure and tissue and bone damage caused by metallic debris. Patients typically cite pain and say they are immobilized by joint dislocations, infections and bone fractures.
The evidence presented against DePuy in both trials was remarkably similar and centered on the fact that the company continued to market the device even after they learned the joint was defective. In both trials internal DePuy documents were introduced that showed beyond a doubt that company officials knew that the design of the A.S.R. was flawed long before they recalled the device and even considered redesigning the implant. The documents also showed that they never shared that information with doctors and patients
It remains unclear why the juries returned such differing verdicts, but in both trials the evidence against DePuy was staggering.
In the Chicago trial the jury was concerned whether the plaintiff’s need for a revision surgery was because of the defect in the product or for some other reason. Apparently, the injured plaintiff in this case continued to have pain and problems even after the DePuy ASR was removed. The DePuy attorneys had argued that the plaintiff had a metal sensitivity to any metal in her body and that her problem would have occurred no matter what type of metal implant she had.
In my experience as a trial lawyer, juries frequently demand stronger evidence than the law requires before they will award millions of dollars in a case. In cases where they have questions about the strength of the evidence they render a defense verdict.
I believe that the evidence is very strong that the DePuy ASR is a defective and dangerous product and that is why it was recalled. The verdict in Chicago certainly did not affirm that the DePuy ASR is a good product. Rather the verdict hinged on the causation of the plaintiff’s pain, not whether the product was defective or not.
The company’s strategy in both trials has so far been one of denial. In his opening statement in Chicago, DePuy attorney Richard Sarver stated, “We absolutely didn’t say the product is a defective product.” To say the recall “is an admission of a defect, it is absolutely absurd.”
Yet in both trials internal documents were introduced that showed consulting surgeons had warned officials at DePuy the implant was faulty and that, by 2008, they knew the cup needed to be redesigned. Even more telling was that DePuy’s own internal estimates that indicated the joint was projected to fail within five years in about 40 percent of the patients. That represents a failure rate eight times higher than most orthopedic implants
DePuy president Andrew Ekdahl downplayed the internal findings and testified that the device was withdrawn, not because it was defective, but simply because “it didn’t meet clinical expectations.”
Yet in the interim between the two trials a study was released by the American Academy of Orthopedic Surgeons, AAOS, which puts the current revision rate of patients with ASR implants at a staggering 40 percent. This number was eerily similar to the 40 percent failure rate DePuy arrived at internally. While the company can continue to attempt to discount its own findings, the study by AAOS is harder to counter.
There are numbers of other jury trials scheduled this year and each case has variations and differences, if DePuy continues with its defense strategy I believe in the end most of the verdicts will be against them. DePuy executives knowingly marketed a defective product and yet they insisted — right up to a moment the device was recalled — that it was safe.
The ASR is one of the worst hip implants ever put on the market and for that reason there is no need to be discouraged by an early defense verdict. With thousands of trials remaining, it will be the job of trial lawyers to fight for the rights of injured consumers and protect them from major corporations like DePuy. The rights of patients, not profits, should always be paramount.
The DePuy A.S.R. is part of the biggest medical device failures in decades and it was the first to be recalled in 2010. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination as well but in that case the metal was leaching from the modular neck joint. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates.

Hip Implant Failures Affect Sex Life

One of the primary reasons for hip replacement is to allow patients to restore the quality of life they had before their hips became a problem. The ability to regain lost mobility and go back to work and exercise are at the top of patients’ list of reasons why they had hip-replacement surgery.
But there is one important quality of life issue that’s almost never mentioned when considering a hip-replacement . . . sex.
In a recent article in the New York Times, (“Surprise Path to Better Sex: Hip Surgery,” April 8, 2013), Tara Parker-Pope writes of how many patients had given up sexual activities because of pain and loss of motion in their joints. But after joint replacement, pain was greatly decreased and motion improved. Most patients reported being able to enjoy pain-free sex again.
In the past decade, the number of hip-replacement surgeries has risen by 85 percent. In 2010 alone, there were over 300,000 hip-replacement surgeries performed. In active middle-age adults, 45-65, the number of hip-replacement surgeries tripled, accounting for 128,000 of that total. In terms of quality of life, a healthy sex life is important, especially in this demographic.
“It’s certainly a topic that is on everyone’s mind, but it’s not a topic that is always spoken about openly,” says Dr. Charles Cornell, clinical director of orthopedic surgery at the Hospital for Special Surgery in New York. Many patients are still hesitant to talk about how joint pain has affected their sex lives.
But it’s beginning to change. Dr. Claudette Lajam, an orthopedic surgeon at New York University Langone Medical Center, said that so many patients have questions about intimacy after joint replacement that she added a page to her Web site devoted to sex. “That page gets the most hits of any page on my Web site,” Lajam says.
Another sign the issue of sex and joint replacement is growing in the public consciousness is when celebrities openly discuss the problem. In a recent interview, the actress and fitness guru Jane Fonda spoke openly of what her hip-replacement meant, “…I’m happier, the sex is better and I understand life better. I don’t want to be young again.”
Along with improving sex lives, hip-replacements can also help improve relationships. When a member of a partnership becomes disabled, it challenges that partnership. The early failure of a hip implant causes significant suffering on the part of both partners in an intimate relationship.
The lawsuits that our firm is filing against hip implant manufacturers DePuy, Stryker, Zimmer, Biomet, Wright Medical and Smith & Nephew all include consortium claims for spouses for the suffering sustained by them and the damage to the sex life of both partners.
A legal consortium claim is much more than just loss of sexual activity it includes all the types of suffering and changes in lifestyle of both partners as a result of a hip implant recall and surgery to replace the defective hip implant. Consortium compensation can include lost companionship, anguish and worry for their partner and for their relationship.
At a jury trial in most states the jury is charged with coming up with a separate figure to compensate the non-physically injured partner for their losses in this category. The recent New York Times article and other public discussion about the sex issue should help jurors hearing lawsuits involving hip implants have a better understanding of what these implant patients and their partners have been going through. This in turn may help increase jury verdict wards for loss of consortium claims in hip implant lawsuits.