Generic Drug Makers Get A Win From Supreme Court

The Supreme Court took away one weapon makers of brand-name drugs have used to fight off generic competition, holding them accountable for what they tell the Food and Drug Administration about their products’ patent coverage. In a rare unanimous decision the court ruled that Caraco Pharmaceutical Laboratories can sue Novo Nordisk for what Caraco claims are exaggerated descriptions of the scope of patents Novo Nordisk holds on the diabetes drug Prandin.

Under federal law governing generic drug approvals, a generic drug maker can market a drug for indications not covered by a current patent held by the branded product’s owner. Frequently a branded drug company will hold a patent on some approved uses but not others and in those cases generic firms can seek approval from the FDA for the unpatented indications.

Caraco sued in federal court, where a district judge agreed that Novo Nordisk had acted improperly. An appeals court then reversed that ruling, arguing that the law gave Caraco no right to sue as long as Novo Nordisk held any unexpired method-of-use patents on the drug, irrespective of the indications covered.

If the Supreme Court would have agreed with the appellate court it would keep generics off the market until all of a branded drug’s method-of-use patents had expired — 2018 in the case of repaglinide. Such a decision would effectively close out the drug sales market from any generic manufacturer and consumers would be the ones to suffer most.

Ultimately this is a decision that will eventually lead to more accessible and affordable prescriptions for all consumers. And so long as we continue to improve the safety and oversight of these medications then both businesses and patients should benefit. This is a good decision for the industry and a good decision for consumers.

If you or a loved one have become sick or injured as a result of taking prescription medication, contact the drug injury attorneys at Lord & Faris for a free consultation. You may have rights at risk.

Should Doctors Have a Financial Interest in Biomedical Products Research?

Should doctors be allowed to perform clinical trial research involving products if they have even an indirect financial stake in that product? It’s a question that is squarely before the FDA and an answer to which Minnesota-based Medtronic has a lot riding.

The product at issue dates back to 2002. At that time a group of FDA advisers met to decide whether or not to approve a powerful agent that promised to revolutionize back surgery. Even then one of the advisors raised initial concerns that some of the research in support of the product had been conducted by a doctor with a financial interest in the product. The rest of the advisors brushed off the concern and proceeded with approval.

Flash forward several years to complaints about the product, including widespread, unapproved use and adverse reactions in some patients that include life-threatening swelling in the neck from bone in unwanted locations and possibly fueling the growth of cancer cells or sparking adverse immune system reactions.

Now Medtronic is back before the FDA seeking approval of a similar product, and the agency and doctors have raised concerns about these adverse reactions and the ties many of the clinical researchers have to the product. It should go without saying that if a researcher stands to make a profit from the approval of a particular product they should not be involved in directing or conducting research in support of that product. But currently there is no hard and fast rule prohibiting such relationships. Given the change in focus by the FDA over the last year, that could change, and if it did, the Minneapolis Drug injury lawyers at Lord & Faris think that consumers would be much better off.

FDA Restricts Avandia | Minneapolis Avandia Attorneys

Citing evidence of significant risk to users, drug regulators in both the United States and Europe announced that the controversial diabetes drug Avandia would no longer be widely available. The move stopped short of a recall but did place significant restrictions on availability.

In Europe the drug’s sales will be suspended entirely, while in the United States patients will be able to access the medication only if their doctors attest that they have tried every other diabetes medicine and that the patient has been made aware of the drug’s substantial heart risks. Even though the move stopped short of a recall it does signal a new era of seriousness by the Food and Drug Administration and it is a move that should be seen as a welcome sign by consumers.

Avandia had been widely touted as a miracle drug, but that was in large part because manufacturers had a tight control over the kind of information that was released about the drug. It was only after a lawsuit, followed by a settlement that forced the manufacturer to publicly list and acknowledge its evidence of heart damage among the dangerous side effects related to the drug.

The Minneapolis Avandia Attorneys at Lord & Faris are glad to see the Food and Drug Administration making a strong statement in this case. If you or your loved ones have taken Avandia or have any questions about the move by the F.D.A. contact our office for a free consultation as you may have a claim.

University of Minnesota, Mayo Clinic Partner to Beat Diabetes

When private industry and the public sector work together, amazing things can happen. That is why the pharmaceutical injury attorneys at Lord & Faris expect great things to come from the announcement that the University of Minnesota and the Mayo Clinic would team up together with the goal of defeating diabetes in 10 years. The only hitch, as the plan was announced, was that to do so the partnership would need an additional $250 to $350 million in public and private funding.

But money issues aside, this announcement comes as terrific news, not only because it represents an enormous public health initiative, and one that the two medical giants have compared to a modern-day “Manhattan Project”, but also because any efforts that support the research into preventing and treating diabetes is a good thing.

The treatment of diabetes costs the state of Minnesota approximately $2.7 billion dollars, and that doesn’t even factor in the problems and complications that can arise from treatments gone bad. Given the fact that Minnesota is a hub for medical and biomedical research, there’s no reason that if the right minds and resources came together this is a problem that could be solved. And when the problem is solved we would not only save money, we would save lives.

Needless to say this is an announcement that Minnesotans, and the rest of the country, should watch carefully. Research into disease prevention and treatment is the best way to protect consumers. As advocates this is just the kind of news we like to hear.

Vaccine Case Argued at Supreme Court | Personal Injury Attorneys Minnesota

Despite many recent setbacks in the courts, those who believe a link between vaccines and certain conditions such as autism had their day before the Supreme Court in a case that many believe could have the potential of bringing sweeping changes in how vaccine challenges proceed.

The case, Bruesewitz v. Wyeth asks the Court to decide whether the National Childhood Vaccine Injury Act of 1986 pre-empts state law tort claims of design defects. If the Court rules that it does, then more than 5,000 families making autism-related vaccine claims may not be allowed to sue vaccine makers in tort actions after they are adjudicated in the so-called “vaccine court” system Congress devised under the Act. In part to keep vaccine manufacturers from leaving the field, Congress established a special system for compensating vaccine injuries. The cases are handled by the claims court in an expedited, no-fault process. Claims are made against the government, not vaccine makers. Compensation is set and manufacturers neither admit nor deny liability.

The law, to a limited degree, appears to leave open the possibility of taking these cases to court after losing in the claims system. Whether or not that can happen is the issue argued before the Supreme Court this week.

Needless to say this is a case our Minneapolis personal injury attorneys will be watching closely. Regardless of the outcome there is no denying that thousands of families have been affected by autism, and many feel strongly that some blame lies with drug manufacturers. The real issue though is just where will those claims be heard.

Class Action Settlement Against UnitedHealth Approved

Another large class action settlement is making news. This one involves the insurance giant UnitedHealth and allegations that it colluded and conspired with others to underpay doctors outside of its network. The final approval of the $350 million class action settlement includes an award of about $89 million in attorneys fees and expenses as well, representing about 25 percent of the cash settlement fund.

The suit dates back to 2000 and has as the plaintiff The American Medical Association and other medical groups, patients, and providers. The lawsuit sought relief for doctors who were harmed by UnitedHealth’s use of a database that determined payments for out-of-network doctors.

After a number of complaints against the practice, the New York Attorney General’s office initiated an investigation. The result of that investigation was a 2009 agreement by UnitedHealth to a $50 million settlement and the closure of the database which the Attorney General at the time said resulted in “unfair reimbursements” to patients. The class action settlement also required the end of the national database.

With the upcoming midterm elections and the unease surrounding federal health care reform, it is important to keep a spotlight on the collusive practices of the insurance industry. Many critics of health care reform argued that any bill would necessarily impact the manner in which doctors get paid–leaving out of course private industry action that already did just that.

But more importantly, the settlement highlights again the need for tough rules regulating insurance companies. As our Minneapolis personal injury attorneys know, these companies will never miss an opportunity to put profit before service.

Wyeth Wins A Second HRT Trial

Defense attorneys scored another win as a Philadelphia jury found that the hormone replacement therapy drug Prempro was not the cause of two Pennsylvania women’s breast cancer. This is the second case successfully defended by Prempro manufacturer Wyeth against allegations that their drug caused cancer in certain patients. In that trial the jury found a lack of factual causation linking the drug to the cancer. However, the jury did find Wyeth had negligently failed to adequately warn about possible risks connected with using Prempro.

The defense verdicts come after three successful plaintiffs verdicts last fall. In those cases jurors awarded over $75 million in damages to a group of plaintiffs, including a large punitive damages award.

Of course, Wyeth points to the defense verdicts, rather than the large plaintiffs verdicts, as proof that while taking their drug does entail some risk, developing breast cancer is not among the foreseeable harms that can be attributed solely to its product. According to Wyeth, anytime a woman undergoes some king of hormone replacement therapy she runs the risk of seeing some biological changes. But isolating those changes to one particular drug at one particular moment is just too speculative to support legal liability.

In a lot of ways the Wyeth litigation illustrates the difficulties facing plaintiffs in drug-related injury cases. Rarely are the medications we take done so in a vacuum, and an injury can have a host of contributing factors. Some of those factors, like smoking, are in the victim’s control while others, like their own genetic code, are not. A third Prempro trial is scheduled for this fall and it will be interesting to see where the jury ends up on this one. Contact the Minneapolis, St Paul Drug Injury Lawyers at Lord and Faris to answer any questions you may have.

FDA Admits Approvals For Medical Device Came After Pressure | Medical Device Injury Lawyers Minnesota

Despite the fact that our jobs often require that our  Minneapolis litigation attorneys see the worst of some situations, we try not to develop a cynicism. But when we read reports like this one from The New York Times, it can be hard not to take a jaded view of the relationship between our regulatory agencies and the industries they are supposed to monitor. In an unprecedented move, the Food and Drug Administration admitted that it approved a medical device after significant pressure to do so. Now, the agency intends to revoke that approval.

The device at issue is a patch for injured knees called Menaflex. According to reports, the patch is so different from earlier devices it should have been tested far more thoroughly before approval. Because that testing did not occur the agency has vowed to move forward with rescinding approval.

This has literally never happened before. In the past when the agency has rescinded an approval it is always on the basis of new information about a product. Never before has the agency admitted that its decision was influenced by politics, let alone suggest that a former commissioner behaved questionably.

So, all in all, we’d have to acknowledge that this is a good step for the agency, and that it represents the kind of transparency we want to see in our governmental agencies. More importantly, we hope that other agencies have the courage to follow the lead of the FDA and work toward re-establishing the necessary boundaries between industry and regulators.

Glaxo Settles Fraud Suit | MN Drug Injury Lawyers Lord and Faris

Avandia managed to make its way back into the news, but not as a result of FDA action. This time the drug was listed as one of many tied to an enormous health care fraud settlement announced by federal and state authorities.

According to reports, pharmaceutical giant GlaxoSmithKline agreed to pay $750 million to settle criminal and civil complaints that for years the company knowingly sold contaminated baby ointment and other products. The settlement comes as a result of a whistleblower suit, placing it in line with a growing number of such cases. But this settlement represents the highest whistleblower award yet in a health care fraud case.

Cheryl Eckard, quality manager for the company, claimed she warned Glaxo of the problems with Avandia, Bactroban, Coreg, Paxil and Tagament. But rather than address her concerns and work toward making those products safe, they fired her. The problems all apparently stem from the manufacturing process plant located in Puerto Rico.

The settlement was announced by both the Department of Justice’s Civil Division and the United States attorney for Massachusetts. Their coordinated prosecution alleged the drug maker misled patients and defrauded federal and state governments that through Medicare and Medicaid, pay for much of health care.

Our Minneapolis Drug Injury Attorneys applaud this settlement and the ongoing efforts by our local investigative agencies to hold these companies accountable for selling contaminated goods. Given all the recent accounts of the government bending to the wishes of the pharmaceutical industry, this is just the kind of reminder we need that there are people looking out for the health, safety and well-being of the American consumer.

Drug Manufacturers Could Soon Face New Claims

When discussing new law, typically those discussions revolve around recently enacted statutes or rules. Rarely do those discussions turn toward new causes of action recognized by a court, but in Pennsylvania, we are and perhaps elsewhere. That’s because in early August a panel of Pennsylvania Superior Court judges ruled that plaintiffs can sue drug manufacturers for a negligent design defect in their drugs, and that such a claim is separate and distinct from a strict liability design defect. While the ruling appears limited to Pennsylvania, it is possible that other jurisdictions, including Minnesota, could follow suit.

The ruling came against drugmaker Pfizer, who has since asked the appeals court to reconsider the ruling. Pfizer’s argument is that a negligent design defect claim would have the effect of second-guessing the federal regulatory regime that oversees all prescription drugs. The manufacturer also argues that the ruling is inconsistent with Pennsylvania law that holds that a Federal Drug Administration-approved prescription drug that contains an adequate warning is not, as a matter of law, defective or unreasonably dangerous.

This new cause of action would allow juries to see what the drug companies did in designing their products, rather than seeing what the companies said to plaintiffs’ doctors about the safety concerns of the drug. Plaintiffs attorneys say that such a claim is the only way to truly monitor ongoing bad practices within the industry.

While it is far too early to tell just whether or not this claim is going to survive, the case is useful in highlighting the fact that even in some areas of what seems to be well-settled law, things can change. That’s part of why we love what we do! Contact our inneapolis Drug Injury Attorneys at Lord and Faris to answer any questions you may have.